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Drug Safety
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Drug Safety
Battle of the Bulge 29 Jan 2006
Such situations leave Alli's fate in doubt. Will the FDA reject the experts' advice to showcase a stronger new post-Vioxx posture about drug safety? ...
- Toledo Blade,
This Year Has To Be Better Than Last — Doesn't It? ByJASJIT S. ... 29 Jan 2006
David Graham, senior drug safety researcher at the Federal Drug Administration, said it all in an interview with Fortune magazine: “Don't be the first to ...
- TheDay (subscription),
Drug Safety Jan 25, 2006
America's drug safety system is deeply flawed according to a new investigation by Consumer Reports. That investigation identified ...
- WOWT,
Drug industry officials see room to improve safety Jan 20, 2006
...reach the market, the officials said. "Drug safety in the US definitely needs improvement. It needs a careful, focused treatment ...
- Reuters
More US patent time suggested for drug safety data Jan 17, 2006
...to complete the studies, some academic experts told an Institute of Medicine panel that is studying the Food and Drug Administration's drug-safety monitoring. ...
- Reuters India,
Safety Issues Played a Role in Vioxx's Withdrawal from the US ... Jan 27, 2006
...excessive marketing. -- Following a long and public drug safety debate in the United States, the FDA must rebuild its reputation. The ...
- Business Wire (press release),
Firms push back against drug-safety calls Jan 19, 2006
19 (UPI) -- Pharmaceutical executives warned Thursday that calls to grant the Food and Drug Administration more power to police drug safety could slow new drug ...
- United Press International
FDA to Simplify Drug Safety Labels Jan 18, 2006
Jan. 18, 2006 -- Doctors will soon see easier-to-understand safety labels on prescription drugs, the FDA announced Wednesday. New ...
- WebMD
New Prescription Drug Information Format to Improve Patient Safety Jan 20, 2006
..."The new label design makes it easier for doctors to get access to important information about drug safety and benefits, and this in turn will help them have ...
- RxPG NEWS,
Medicare drug safety net extended; legislators wonder who pays Jan 21, 2006
By Aaron Sadler. LITTLE ROCK - Gov. Mike Huckabee on Friday extended a stopgap measure to help senior citizens receive medication ...
- Arkansas News,
New safety scheme in Tallaght Hospital highlights common drug ... Jan 20, 2006
In the analysis carried out by Ms Quirke, who is Drug Safety Co-ordinator at the Hospital, of 102 prescribing errors reported between January and mid-November ...
- Irish Medical News,
FDA Advises Researchers on Testing Drug Safety, Effectiveness Jan 12, 2006
WASHINGTON — Concerned by a system in which more than nine out of 10 experimental drugs fail when tested in humans, the Food and Drug Administration issued ...
- FOX News
FDA to Take New Look at ADHD Drug Safety Jan 4, 2006
Now the US regulatory agency is asking its Drug Safety and Risk Management advisory committee to examine ways of studying further the potential cardiovascular ...
- FOX News
Chinese vice premier stresses food, drug safety Jan 12, 2006
Chinese Vice Premier Wu Yi highlighted food and drug safety at a meeting in Beijing Thursday, urging food and drug authorities to strengthen supervision. ...
- People's Daily Online,
Drug safety wrong issue for courts Jan 3, 2006
...of Vioxx, the controversial painkiller, should give doctors, hospitals and journal authors reason to think harder about how drug safety information is processed ...
- Toronto Star,
Expert Opinion on Drug Safety Launches an Open-Access ... Jan 6, 2006
LONDON, January 6 /PRNewswire/ -- Since the withdrawal of Vioxx, issues surrounding drug safety, adverse events and pharmacovigilance have become more ...
- PR Newswire (press release),
FDA to probe ADHD drug safety Jan 5, 2006
The Drug Safety and Risk Management Advisory Committee will be asked to discuss approaches that could be used to study whether these products increase the risk ...
- Pharma Times (subscription),
Beebe ask DHHS to provide drug safety net for Medicare recipients Jan 10, 2006
By Wesley Brown. LITTLE ROCK - Attorney General Mike Beebe asked the state human services agency Monday to step in and help seniors ...
- Arkansas News,
Drug-safety comments encouraged Jan 6, 2006
The nation's top drug-safety experts are being stymied and demoralized by political overseers who ignore science, a former Food and Drug Administration leader ...
- DesMoinesRegister.com,
Drug Commonly Used in Surgery Doubles Risk of Kidney Failure Jan 26, 2006
Read more... “Certainly, our findings—coming on the heels of the Vioxx experience—indicate that the problem of drug safety is not only ubiquitous, but ...
- SeniorJournal.com,
FDA questions safety and effectiveness of OTC GSK diet pill Jan 22, 2006
But Madelyn Fernstrom, of the Weight Management Center at the University of Pittsburgh Medical Center stuck by the drug's safety. ...
- Earthtimes.org
Contact: Tyler Prell of The Hauser Group for IREF, 202-518-8047 (8 ... Jan 25, 2006
Dennis T. Mangano, Ph.D., MD "Certainly, our findings -— coming on the heels of the Vioxx experience -— indicate that the problem of drug safety is not ...
- U.S. Newswire (press release),
Drug used worldwide doubles risk of kidney failure Jan 26, 2006
...scientist, Dennis T. Mangano, Ph.D., MDsays the study, which comes hot on the heels of the Vioxx experience,indicates that the problem of drug safety is not ...
- News-Medical.net,
RxGen Announces the Formation of RxGen PrimaTox, Inc. (RxP), a ... Jan 26, 2006
...announced that it has formed RxGen PrimaTox Inc., a wholly owned subsidiary that is focused on drug safety products and services to improve the preclinical and ...
- Genetic Engineering News,
Sanofi's Ketek antibiotic safety profile unchanged Jan 21, 2006
Reuters) - French drugmaker Sanofi-Aventis SA (SASY.PA: Quote, Profile, Research) is standing by its antibiotic Ketek, saying the drug's safety profile remains ...
- Reuters
Sanofi's Ketek antibiotic safety profile unchanged Jan 21, 2006
...is standing by its antibiotic Ketek, saying the drug's safety profile remains unchanged even though doctors have found three patients suffered severe liver ...
- Reuters.uk,
Sanofi's Ketek antibiotic safety profile unchanged Jan 21, 2006
PARIS (Reuters) - French drugmaker Sanofi-Aventis SA is standing by its antibiotic Ketek, saying the drug's safety profile remains unchanged even though ...
- Reuters
Study: Cardiac Drug Doubles Risk of Kidney Failure Jan 26, 2006
..."Certainly, our findings -- coming on the heels of the Vioxx experience -- indicate that the problem of drug safety is not only ubiquitous, but also much more ...
- Consumer Affairs
Glaxo seeks approval to sell obesity drug over the counter Jan 22, 2006
The vote, and subsequent decision by the agency, will be the latest test of how FDA is weighing concerns about expanded access to medicines and drug safety. ...
- Pittsburgh Post Gazette,
High-Cost Use of Second-Generation Antipsychotics Under ... Jan 25, 2006
...a large state hospital system. Pharmacoepidemiology and Drug Safety 12:41–48,2003[CrossRef][Medline]. Tapp A, Wood AE, Secrest ...
- Psychiatric Services (subscription)
Sanofi's Ketek antibiotic safety profile unchanged Jan 21, 2006
Jan 21, 2006 — PARIS (Reuters) - French drugmaker Sanofi-Aventis SA is standing by its antibiotic Ketek, saying the drug's safety profile remains unchanged ...
- ABC News
ProSanos Receives Grant from the Department of Defense to Develop ... Jan 24, 2006
The grant will be used for research to apply ProSanos's drug safety technology to DOD needs; specifically, the funds will be used to augment clinical trial ...
- Genetic Engineering News,
Association of PrMACUGEN* (pegaptanib sodium injection) with ... Jan 23, 2006
Drug Safety PO Box 800 Pointe-Claire-Dorval, Quebec H9R 4V2 Tel: 1 800 463-6001 (Medical Information) Any suspected adverse reaction can also be reported to ...
- Canada NewsWire (press release),
Bayer's Trasylol may cause kidney failure Jan 25, 2006
..."Studies such as the one by Mangano and colleagues point the way to the prospective design of studies to assess drug safety and to the collection of as much ...
- United Press International
Blouin touts plan for senior health care Jan 27, 2006
...them to have choices in health care as they age, provide high-quality residential home and community-based care, increase prescription drug safety and reduce ...
- Marshalltown Times Republican,
A DOSE OF SAFETY FOR PRESCRIPTIONS Jan 23, 2006
For more drug safety advice: Check out the nonprofit Institute for Safe Medication Practices’ Web site at www.ismp.org . — Prevention Magazine.
- Kansas City Star,
FDA Plan Would Aid Drug Makers In Liability Suits Jan 14, 2006
...longer. Merck and other companies have often struggled to explain the scientific nuances of their drug-safety defenses to juries. ...
- Wall Street Journal
Biotech Drug Said to Be Useful Against a Rare Blood Ailment Jan 25, 2006
...based in Cheshire, Conn., said it planned to file for regulatory approval by the end of the year, after completing another trial focused on the drug's safety. ...
- New York Times,
GTx's Phase III Clinical Development of ACAPODENE on Course ... Jan 19, 2006
...the Men's Health Biotech Company, today announced that a per protocol interim safety review by an independent Drug Safety Monitoring Board (DSMB) recommended ...
- PharmaLive.com (press release),
Safety of ADHD drugs studied Jan 5, 2006
Now, the US regulatory agency is asking its drug safety and risk management advisory committee to examine ways of studying further the potential cardiovascular ...
- London Free Press,
Feds simplify Rx labels, but some protest Jan 18, 2006
DC, United States (UPI) -- The Food and Drug Administration unveiled new regulations Wednesday that agency officials said simplify drug safety labels and make ...
- Monsters and Critics.com,
Feds simplify Rx labels, but some protest Jan 18, 2006
18 (UPI) -- The Food and Drug Administration unveiled new regulations Wednesday that agency officials said simplify drug safety labels and make it easier for ...
- United Press International
GTx moves ahead with Acapodene Jan 19, 2006
After reviewing the clinical data, the Drug Safety Monitoring Board recommended that GTx continue clinical development as planned. ...
- Memphis Business Journal,
FDA will study safety of attention-deficit drugs Jan 5, 2006
Now the US regulatory agency is asking its Drug Safety and Risk Management advisory committee to examine ways of further studying the potential cardiovascular ...
- Kansas City Star,
French defend drug after patients develop liver problems Jan 24, 2006
...with Ketek. But the French drug company Sanofi-Aventis is standing firm and says the drug's safety profile remains unchanged. They ...
- News-Medical.net,
For drug inserts, a dose of clarity Jan 19, 2006
This week, an arm of the National Academies of Sciences has been holding hearings on the drug safety system. Rob Schneider, who ...
- Baltimore Sun,
UPDATE: J&J Meets 4th-quarter Profit Target, Misses On Revenue Jan 24, 2006
Weldon also said heightened public fears over drug safety have weighed on sales of its cardiac drug Natrecor and birth-control patch Ortho Evra. ...
- Business Online,
Drug company harasses honest regulator Jan 20, 2006
...to expose the too cozy relationship between the [FDA] and the drug industry -- Dr. Hampshire's hard work and dedication to science and drug safety placed a ...
- Topeka Capital Journal (subscription),
Cardiac, Neuropsychiatric Events From ADHD Drugs To Be Discussed ... Jan 25, 2006
...to ADHD medications,� FDA noted. FDA’s Drug Safety & Risk Management Advisory Committee is meeting Feb. 9-10 to discuss studies ...
- FDA Advisory Committee
FDA to examine new ways of studying safety of attention-deficit ... Jan 4, 2006
Because of that and other incidents, the agency is asking its Drug Safety and Risk Management advisory committee to examine ways of further studying the ...
- KLFY,
FDA to Examine New Ways of Studying Safety of Attention-Deficit Jan 5, 2006
Because of that and other incidents, the agency is asking its drug safety and risk management advisory committee to examine ways of further studying the ...
- WDTN,
Federal medicine oversight criticized Jan 11, 2006
Congress should build more independence and authority into US drug-safety oversight to protect consumers from potential risks of medicines such as Merck & Co ...
- Arizona Daily Star,
Safety board OKs continuation of pivotal GTx cancer trials Jan 20, 2006
Following an interim safety review, an independent drug safety monitoring board has recommended that GTx continue clinical development as planned with its two ...
- Pharmaceutical Business Review
DrugLogic(R), Inc. Announces the Production Release of Qscan(R) ... Jan 19, 2006
Qscan(R) 3.2 incorporates drug safety research tools integrated to support the complete drug safety workflow and multiple database environments. ...
- Genetic Engineering News,
FDA revamps rules for drug package inserts Jan 20, 2006
...inserts have been updated for the first time in 25 years, requiring drug makers to provide doctors with easier access to important information about drug safety ...
- In-PharmaTechnologist.com,
Pharmacy Board Opens Inspection Unit Jan 25, 2006
She disclosed that her Ministry would be officially launching a Drug Safety Monitoring Programme to address drug safety issues. ...
- AllAfrica.com,
DrugLogic(R), Inc. Announces Availability and Pilot Program of ... Jan 19, 2006
...additional charge. Qscan(R)-VAERS incorporates the drug safety research tools that have been improving for the past six years. As ...
- Genetic Engineering News,
United BioSource Hires Industry Expert Jeannine Bender, PhD as ... Jan 26, 2006
Bender brings over 20 years of health care public policy and government affairs experience, with a focus on Medicare and Medicaid, drug safety and reimbursement ...
- PharmaLive.com (press release),
ADHD Drug Cardiac Events, COX-2s Are Topics For Drug Safety ... Jan 5, 2006
...will be discussed at a Feb. 9-10 meeting of FDA’s Drug Safety & Risk Management Advisory Committee. “Cases of sudden death and ...
- FDA Advisory Committee
Drug rule may reduce errors Jan 25, 2006
...prescribe medications," Rice said. Jerry Phillips, R.Ph., president of the Drug Safety Institute, concurs. "The new highlights section ...
- myDNA.com,
Studies: Antidepressants don't cause suicides Jan 1, 2006
...about adults, but "it doesn't, however, alter our ongoing concern about children," cautioned Dr. Paul Seligman, who heads FDA's Office of Drug Safety. ...
- Contra Costa Times,
Bristol-Myers Hopes to Settle Vanlev Matter Jan 23, 2006
...side effects, making "materially false and misleading statements" or failing to disclose "material information" about the drug's safety, effectiveness and ...
- TheStreet.com
International Research Reveals Proven Ways To Reduce Drug Costs Jan 5, 2006
Furberg is widely recognized as a drug safety expert and has served on the FDA Drug Safety and Risk Management Advisory Committee. ...
- WFMY News 2,
NovaScreen Launches New 48-Kinase Profiling Panel Jan 19, 2006
New Kinase Screening Service Reveals Potentially Critical Drug Safety Information HANOVER, Md., Jan. 19 /PRNewswire/ -- NovaScreen ...
- PR Newswire (press release),
New Rule Results In The Complete Makeover In The Field Of Drug ... Jan 20, 2006
The FDA announced that the drug labels should contain a highlight section, which gives the gist of the information regarding drug safety. ...
- MedIndia,
US: Opposition to Drug Co. Liability Protection Grows Jan 2, 2006
In a statement Monday, the National Autism Association (NAA) termed the measure "an affront to democracy" and warned that it will undermine drug safety in the ...
- CorpWatch.org,
Illegal Bird Flu Medicine Continues Pouring into US Jan 20, 2006
...health implications of unapproved prescription drugs from businesses seeking to profit by circumventing US legal standards for drug safety and effectiveness ...
- The Conservative Voice,
Suicide Risks and SSRIs Jan 17, 2006
The head of FDA's Office of Drug Safety concedes the study is “important,� but contends that "it doesn't alter our ongoing concern about children." An ...
- American Enterprise Institute,
(PRN) - Franklin Bank Announces 4th Quarter 2005 Earnings ... Jan 6, 2006
Television Display ... [+. PRN) - Expert Opinion on Drug Safety Launches an Open-Access Correspondence Section ... [+. PRN) - Pioneer ...
- Bolsamania.com,
Doctors highlight the controversial problems of the FDA and Big ... Jan 10, 2006
Not only do Americans not trust the industry, but there is a crisis of confidence in the FDA as an impartial arbiter of drug safety and effectiveness. ...
- Newstarget.com,
FDA Orders Closer Look at ADHD Drug Risks Jan 5, 2006
The FDA has requested its Drug Safety and Risk Management advisory committee to consider how to further study the potential cardiovascular risks of ADHD drugs ...
- HealthCentral.com
Charles River tries new growth strategy Jan 23, 2006
Pharmaceutical companies are striving to weed out drugs likely to fail earlier in the process, as they struggle with the aftermath of drug safety scandals that ...
- Reuters
Solvay Pharmaceuticals Names Harold H. Shlevin, Ph.D., as Global ... Jan 19, 2006
...organization will align several important areas of the global Solvay Pharmaceuticals organization including global quality, global drug safety and surveillance ...
- Business Wire (press release),
HIV drug treatment must be constant to be effective, researchers ... Jan 18, 2006
The US National Institute of Health enrolled more than 5,000 HIV patients in 33 countries, including Canada, in the drug safety trial. ...
- CBC - Newfoundland & Labrador,
Drug improves nighttime urination in men Jan 17, 2006
..."We need to recognize this drug's safety and correct application," Dr. Chih-Shou Chen from Chang Gung Memorial Hospital, Chia-Yi, told Reuters Health. ...
- Financial Express,
FDA Needs More Independence, Authority To Protect Consumers, NEJM ... Jan 12, 2006
Congress should give more independence and authority to drug safety oversight to help protect consumers from potential risks of medicines, Wayne Ray ...
- Kaiser network.org,
Consumer Reports: Prescription for trouble Jan 3, 2006
America's drug-safety system is deeply flawed, according to a just-published investigation by Consumer Reports. It has identified ...
- WFAA (subscription),
The fool's gold that heals Jan 13, 2006
Dr David Graham of the FDA told a US Senate hearing in October 2004 that his agency's approval of Vioxx led to the 'single greatest drug safety catastrophe in ...
- Guardian Unlimited,
Pfizer to pay Sanofi-Aventis $1.3 billion for full rights to ... Jan 13, 2006
...cautious of prescribing new drugs. Pfizer has pledged to continue studying the drug's safety after its approval. The $1.3 billion also ...
- CBC News,
Phase Forward Announces Fourth Quarter Financial Reporting Date ... Jan 13, 2006
Phase Forward Incorporated (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced today that it will ...
- Genetic Engineering News,
US Still Hopes To Conclude Free Trade Pact with Thailand Jan 13, 2006
...regarding data protection, which protects the detailed data that companies must provide the Thai Government to prove a drug's safety and effectiveness so it ...
- Washington File,
Earlier drug tests on people OKd Jan 13, 2006
1 trials, designed to clarify which doses are acceptable and which are toxic, and Phase 2 and Phase 3 trials, designed to determine a drug's safety and whether ...
- Chicago Tribune,
Website provides food, drug information Jan 5, 2006
BEIJING, Jan. 6 -- The Shanghai Food and Drug Administration yesterday announced it established a Website providing food and drug safety information. ...
- Xinhua,
J&J: deaths unreported in drug study Jan 3, 2006
...unreported two additional patients died 30 days after taking its Natrecor heart failure drug in a long-term study, adding to uncertainty about the drug's safety ...
- CNN/Money
Supreme Court Upholds Oregon Physician-Assisted Suicide Law Jan 17, 2006
Justice Anthony Kennedy, who wrote the majority decision, said the government has the right to prosecute drug dealers and to pass laws that regulate drug safety ...
- MedPage Today,
US warns of brand errors in imported drugs Jan 12, 2006
The rules will allow companies to produce much earlier data on a drug's safety by using new gene-based techniques to test small amounts of drugs in the lab ...
- International Herald Tribune,
NovaDel Stockholders Approve Board Members At Annual Stockholders' ... Jan 17, 2006
...proprietary oral spray technology delivery system offers the patient the potential for (i) fast onset of action; (ii) improved drug safety by reducing the ...
- Genetic Engineering News,
Nektar up on Pfizer Exubera buyout Jan 13, 2006
...lung function and coughing. Pfizer has promised to continue studying the drug's safety following approval. Deutsche Bank agreed ...
- BusinessWeek
FDA issues guideline revisions for drugmakers Jan 13, 2006
Citizen. The nonprofit consumer-advocacy organization monitors drug safety and has been critical of the FDA's oversight. Extensive ...
- Northwest Herald,
Tyco will divide into 3 companies by early 2007 Jan 14, 2006
...called Exhubera, by three months. Pfizer has pledged to continue studying the drug's safety after its approval. Pfizer also will gain ...
- Indianapolis Star,
Beijing to collect expired medicine Jan 20, 2006
21 -- Collection boxes will be set up in Beijing to recover expired medicine in every residential quarter in a bid to promote drug safety, according to the ...
- Xinhua,
J&J says two deaths unreported in Natrecor study Jan 3, 2006
...it published results of its 30-day analysis of death by all causes among patients taking Natrecor or a placebo, adding to uncertainty about the drug's safety. ...
- Reuters
Prescription for Trouble Jan 8, 2006
...of these drugs, Consumer Reports says the risks are rare, and a few are not conclusively proven, but they point to weaknesses in the nation's drug-safety system ...
- ABC30.com,
Phase Forward Announces Fourth Quarter Financial Reporting Date ... Jan 13, 2006
Jan 13, 2006 - Phase Forward Incorporated (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced today ...
- PharmaLive.com (press release),
CHI Issues Statement on Gov. Schwarzenegger's Call for Federal ... Jan 3, 2006
Congress has charged the US Food and Drug Administration (FDA) with responsibility for drug safety, and any system of foreign importation should conform to FDA ...
- Business Wire (press release),
Headache tops most frequently-caught diseases for Chinese ... Jan 11, 2006
...diseases for urban residents in China, with people aged between 30 and 45 accounting for over 70 percent, according to the first national drug safety survey. ...
- Xinhua,
Understand the Impact of Regulatory Reform and Raised Drug Safety ... 23 Nov 2005
A number of high-profile drug safety issues (including the withdrawal of Vioxx in late-2004, and investigation of the links between SSRIs and suicide) are ...
- Genetic Engineering News,
Abortion pill to be studied after four women die of bacterial ... 23 Nov 2005
...died after taking an abortion pill suffered from a rare and highly lethal bacterial infection, a finding that is leading to new scrutiny of the drug's safety. ...
- Minneapolis Star Tribune (subscription),
Alexion Thumped After Drug Failure 23 Nov 2005
...significance. The trial, which was also conducted to study the drug's safety, involved 4,250 patients at 250 sites worldwide. "We ...
- TheStreet.com
Health Highlights: Nov. 23, 2005 23 Nov 2005
...abortion pill had a rare, deadly Clostridium sordellii bacterial infection, say US federal drug regulators, who plan to take a closer look at the drug's safety ...
- Austin American-Statesman (subscription),
Drug Side Effects Kill Tens of Thousands of Seniors Annually 23 Nov 2005
Genelex Corporation, Seattle, Washington is a DNA testing laboratory dedicated to improving drug safety and efficacy for consumers and their health-care ...
- PR Newswire (press release),
Pharma To Republicans - Time To Pay Up Again 23 Nov 2005
...vaccines and grants the Secretary of the Department of Health and Human Services, the sole authority to determine whether a drug maker violated drug safety laws ...
- OpEdNews
Merck chief quits after 'personal' clash 23 Nov 2005
The withdrawal led to a £14billion slump in Merck's market value at the same time as sparking a worldwide furore over drug safety issues. ...
- Telegraph.co.uk,
NovaDel Pharma Inc. Announces New Record Date for Annual ... 23 Nov 2005
...proprietary oral spray technology delivery system offers the patient the potential for (i) fast onset of action; (ii) improved drug safety by reducing the ...
- PharmaLive.com (press release),
Making Sense of Drug Safety Nov 15, 2005
Moreover, given the current fervor at FDA for ensuring drug safety, and the difficulty of proving a negative, one wonders how a "suspect" drug could ever clear ...
- Tech Central Station,
Insightful's Dr. Michael O'Connell to Participate in DIA's Webinar ... Nov 22, 2005
..."The assessment and monitoring of drug safety is an important current challenge in the pharmaceutical industry," said Dr. O'Connell. ...
- Genetic Engineering News,
ICM Adds Drug Safety Module to VIZYX Compliance Management Suite Nov 1, 2005
1, 2005--ICM has released a drug safety module to VIZYX, the only integrated compliance management software suite developed exclusively for life sciences ...
- Business Wire (press release),
FDA and Biogen Idec Issue Drug Safety Alert Concerning Fatal ... Oct 30, 2005
...events have been associated with Rituxan (rituximab), a component of the Zevalin therapeutic regimen according to the senior director of drug safety and risk ...
- Newsinferno.com,
Deaths lead to Tamiflu safety check Nov 17, 2005
Drug safety regulators in the US and Europe are reviewing the safety of the anti-flu drug Tamiflu among children and adolescents after reports of 12 deaths and ...
- Guardian Unlimited,
FluWrap: Tamiflu gets safety nod Nov 18, 2005
...and Drug Administration panel did suggest adding warnings about possible serious skin conditions, and said the FDA should review the drug safety profile again ...
- Science Daily (press release)
BLACK BOX WARNINGS OFTEN GO UNHEEDED Nov 22, 2005
...the Food and Drug Administration (FDA) can issue -- on prescription drugs, according to a study published in the journal Pharmacoepidemiology and Drug Safety. ...
- National Center for Policy Analysis,
Vioxx Users to Challenge Safety Claims Nov 16, 2005
...painkiller Vioxx can be lethal if taken for just a few weeks will be the crux of the first federal trial concerning the drug's safety, plaintiff's lawyers said ...
- MSN Money
Safety key in abortion debate: Coonan Nov 15, 2005
...use in rural areas. Senator Coonan said the drug's safety in relation to all women was the key issue in the debate. "I think the ...
- Sydney Morning Herald (subscription),
Grassley Demands Answers on Safety of US Experimental Drugs Nov 8, 2005
Grassley last year began an investigation of the FDA's handling of drug- safety issues after the withdrawal of Merck & Co.'s Vioxx painkiller. ...
- Bloomberg
USA Today Profiles FDA Associate Director Graham Nov 17, 2005
David Graham, associate director for science and medicine at the FDA's Office of Drug Safety, said that not much has changed at the agency in the year since he ...
- Kaiser network.org,
Floor Statement of US Senator Chuck Grassley of Iowa - One-Year ... Nov 18, 2005
...drug. Dr. Hampshire’s hard work and dedication to science and drug safety placed a bulls eye on her reputation and career. Without ...
- PharmaLive.com (press release),
Most Recent Vioxx Study Shows Merck Will Need More Than Courtroom ... Nov 14, 2005
May 14, 2002 – E-mail from Ann Trontell, FDA deputy drug safety director, warned colleagues that a Merck official had reminded her that "there had been an ...
- Newsinferno.com,
ICM Adds Drug Safety Module to VIZYX Compliance Management Suite Nov 2, 2005
ATLANTA, GA -- November 1, 2005 -- ICM has released a drug safety module to VIZYX, the only integrated compliance management software suite developed ...
- dBusinessNews Atlanta (press release),
Warning labels on high-risk drugs inconsistently heeded by doctors Nov 21, 2005
49.6 percent. These results are reported online in the Nov. 18, 2005 issue of Pharmacoepidemiology and Drug Safety. "In ambulatory ...
- innovations report,
Three drug testers claim SFBC threatened them Nov 20, 2005
...speed development of profitable new drugs, says Peter Lurie, deputy medical director of Public Citizen, a Washington, DC, group that monitors drug-safety issues ...
- Seattle Times,
Study: Rx Warnings Ignored Nov 22, 2005
18 issue of Pharmacoepidemiology and Drug Safety, the researchers collected information about 917,000 ambulatory-care patients from across the country over a ...
- Harvard Crimson,
FDA: Not Enough Evidence To Blame Deaths On Tamiflu Nov 18, 2005
...to establish a direct causal relationship between the use of (Tamiflu) and the reported deaths," said Melissa Truffa of the FDA's Office of Drug Safety. ...
- NBC4i.com,
Doctors Not Heeding 'Black-Box' Warnings on Rx Drugs Nov 18, 2005
18 issue of Pharmacoepidemiology and Drug Safety. ... Visit the FDA's Office of Drug Safety (www.fda.gov ) for more on these issues. ...
- KPHO Phoenix,
Doctors Not Heeding 'Black-Box' Warnings on Rx Drugs Nov 18, 2005
...published their findings online in the Nov. 18 issue of Pharmacoepidemiology and Drug Safety. "We need to think about communicating ...
- ABC News
Stocks: A Roast for 2005's Turkeys... Nov 22, 2005
Fund (LOGSX ). Now the stock has rebounded to $45, and the Food & Drug Administration is reviewing the drug's safety. For investors ...
- BusinessWeek
Direct link between Tamiflu, deaths in Japan not shown: FDA Nov 18, 2005
...with the US Food and Drug Administration studied the cases, along with other possible side effects from Tamiflu, during a routine review of the drug's safety. ...
- CBC Edmonton,
NeoPharm Announces Precise Trial Update Nov 21, 2005
It is designed to enroll up to 300 patients, and compare overall survival, drug safety and quality of life of patients receiving cintredekin besudotox with ...
- Business Wire (press release),
Health Highlights: Nov. 20, 2005 Nov 20, 2005
Melissa Truffa, of the FDA's Office of Drug Safety, told the panel earlier Friday that they found no direct link between the use of Tamiflu and the deaths in ...
- ABC News
Flu Medication Is Called Safe Nov 19, 2005
Tamiflu and the deaths. Melissa Truffa of the FDA's Office of Drug Safety said there were too many factors involved. They include the ...
- Hartford Courant,
Multiple forms of same drug resulting in errors Nov 21, 2005
...the last thing we want to do is cause more confusion," said Carol Holquist, director for the division of medication errors in the FDA's office of drug safety. ...
- philly.com,
Calendar: Healthy happenings Nov 20, 2005
Child care provided. (803) 738-1480. • SC Alcohol and Drug Safety Action Program is required for all people convicted of DUI in South Carolina and those who ...
- The State,
Kaiser Daily Women's Health Policy Report Summarizes Opinion ... Nov 19, 2005
The agency "should approve the application and keep political considerations out of its drug safety decisions," the editorial concludes ( Austin American ...
- Medical News Today (press release),
Doctors often ignore 'black box' warnings on prescription drugs Nov 18, 2005
But a study just published in the journal Pharmacoepidemiology and Drug Safety found that doctors don't always heed the drug makers' guidance. ...
- U.S. News & World Report
Slimming drug takes weight and memory Nov 19, 2005
By TARA ROSS. New Zealand research into the weight-loss pill Reductil raises new questions over the drug's safety. More than 17,400 ...
- Stuff.co.nz,
FDA panel says no evidence Tamilflu linked to deaths Nov 18, 2005
But the the committee data review also highlighted the FDA's new, quicker reflexes to air publicly concerns over drug safety. Scrutiny ...
- MSNBC
Many Physicians, Patients Do Not Comply With Black Box Warning ... Nov 18, 2005
...warning that FDA can issue -- on prescription drugs, according to a study published on Friday in the journal Pharmacoepidemiology and Drug Safety , the Wall ...
- Kaiser network.org,
Contraception Emergency Nov 16, 2005
If the FDA continues to inject politics into drug decisions, it will undermine the credibility of its evaluations of drug safety. ...
- Harvard Crimson,
Study: black box warnings often ignored Nov 21, 2005
49.6 percent. The results of the study are reported online at the Web site of the journal Pharmacoepidemiology and Drug Safety.
- Science Daily (press release)
Abbott's views shaping pill debate: ALP Nov 16, 2005
...way to have a termination is a surgical termination" - but he did not say his brief to his department had only asked for advice on the drug's safety in remote ...
- The Age (subscription),
FDA: Cozy with drugmakers Nov 8, 2005
Under fire over drug safety and under pressure to speed new treatments to market, the Food and Drug Administration spent more than $400 million last year ...
- CNN
Abbott heart drug shows scant survival benefit Nov 16, 2005
Weinstein said US regulators will likely require more trial data on the drug's safety and effectiveness, particularly in view of recent questions about the ...
- Reuters AlertNet,
SFBC Threatens Human Drug Testers for Exposing Risks (Update1) Nov 16, 2005
...development of profitable new drugs, says Peter Lurie, deputy medical director of Public Citizen, a Washington-based group that monitors drug safety issues. ...
- Bloomberg
Congress reduces its oversight role Nov 20, 2005
Grassley took on both the pharmaceutical lobby and the Bush administration when he held hearings on prescription drug safety and the FDA's relationship with ...
- Boston Globe,
Phase Forward Reports Third Quarter Results; Achieves 17% Revenue ... Nov 1, 2005
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced its financial results for ...
- Genetic Engineering News,
Phase Forward Reports Third Quarter Results; Achieves 17% Revenue ... Nov 1, 2005
WIRE)--Nov 1, 2005 - Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced its ...
- PharmaLive.com (press release),
Published Study: Automated Mail-Order Dispensing Accuracy Sets ... Nov 8, 2005
Drug Safety Excessive pharmacist workload at retail pharmacies is one factor leading to a higher occurrence of prescription errors. ...
- PR Newswire (press release),
PM considers conscience vote on pill Nov 17, 2005
However, the health department's chief medical officer Professor John Horvath has revealed he was asked for only limited advice on the drug's safety in remote ...
- The Age (subscription),
» No evidence to link Tamiflu with child deaths Nov 19, 2005
...years time. This because they were convinced that the FDA is committed to keep the public informed over drug safety concerns. It ...
- What is the Word,
Politics on drugs Nov 16, 2005
...experts have determined. The agency should approve the application and keep political considerations out of its drug safety decisions.
- Austin American-Statesman (subscription),
Tamiflu's Role In Children's Death Still Unknown Nov 18, 2005
An outside panel will advise the FDA if it should continue to follow the drug's safety in children and report back within two years.
- KDKA,
Abortion free vote supported Nov 18, 2005
...women. Mr Costello did not say how he would vote, reserving his decision until after assessments of the drug's safety had been made. ...
- Sydney Morning Herald (subscription),
FDA looks to move beyond black-box warning Nov 18, 2005
Wagner and colleagues wrote in the Nov. 18 issue of Pharmacoepidemiology and Drug Safety. The finding "indicates the need for better ...
- United Press International
PM considers free vote on pill Nov 17, 2005
Acknowledging the hotly disputed claims over the drug's safety, Mr Howard said he would seek further detailed advice from experts. ...
- The Age (subscription),
Doctors Do Not Excise Sufficient Caution While Prescribing High ... Nov 18, 2005
BBWs are warnings printed in a black frame in the package insert of a drug. It contains details regarding the drug safety, precautions and adverse effects. ...
- MedIndia,
Jurors begin deliberations in Merck safety-warning case Nov 2, 2005
...that it had given all data on Vioxx tests, either in raw form or in finished reports, to Food and Drug Administration regulators to judge the drug's safety. ...
- Philadelphia Inquirer,
Clinical Briefs For November 2005 Oct 30, 2005
We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications.". ...
- U.S. Medicine,
Patch problems prompt warning Nov 16, 2005
According to federal drug safety reports, a dozen women, most about 20 years old, died in 2004 from blood clots thought to be related to the patch, and dozens ...
- The Orion,
Expert advice on new drugs Nov 1, 2005
...physician who writes and lectures about pain management, said he expects patients to keep asking for prescriptions despite heightened concerns about drug safety ...
- Newsday,
Patients report drug side-effects Oct 25, 2005
The Yellow Card Scheme was set up in 1964 for health professionals to report suspected drug safety hazards following the Thalidomide tragedy. ...
- Daily Mail - UK,
Study gives tips for improving trials Nov 11, 2005
...others to examine their data and verify their results is the only way to solve the problems we have with inadequate reporting on drug safety and effectiveness ...
- Science Daily (press release)
FDA reviewer battles the drug his boss approved Oct 26, 2005
Also, Dr. Orloff says he prefers having one reviewer on a drug and Dr. Roman was the logical choice because he had focused on the drug's safety. ...
- Pittsburgh Post Gazette,
Community Announcements > TechLINKS - The Guide to Technology in ... Nov 1, 2005
ICM has released a drug safety module to VIZYX, the only integrated compliance management software suite developed exclusively for life sciences companies. ...
- TechLINKS (press release),
Professor Bill Inman Oct 27, 2005
...up scheme was needed, and in 1980, when the Health Department refused to support his ideas, he decided to go it alone and founded the Drug Safety Research Unit ...
- Telegraph.co.uk,
Drug warnings inconsistently heeded Nov 18, 2005
...categories, prescribing is inconsistent with the warnings.". These findings are reported online in Pharmacoepidemiology and Drug Safety.
- United Press International
Asbestos drug gets fast-track status Nov 19, 2005
...trials to determine dosages is complete. Phase two began in late October, in which the drug's safety and effectiveness are confirmed.
- The Japan Times,
AP: Merck Tried to Alter Vioxx in 2000 Nov 3, 2005
...emerge since the drug's sales were suspended because it calls into question the bedrock Merck defense that company officials were convinced of the drug's safety ...
- Allentown Morning Call,
Phase Forward Reports Third Quarter Results Nov 2, 2005
Mass., November 1, 2005 – Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced ...
- PharmaLive.com (press release),
Inconsistent Adherence to Black Box Warnings: A Newsmaker ... Nov 18, 2005
...survey reported online in the Nov. 18 issue of Pharmacoepidemiology and Drug Safety. The Investigators in this retrospective study ...
- Medscape (subscription)
What's A Reasonable Royalty Rate? Nov 17, 2005
This type of study is conducted on patients with the targeted disease that the drug is intended to treat over two years to test the drug's safety and efficacy. ...
- Patent Baristas,
Federal Vioxx plaintiffs challenge Merck's "18-month myth" Nov 16, 2005
Vioxx can be lethal if taken for just a few weeks will be the crux of the upcoming first federal trial concerning the drug's safety, plaintiff's lawyers said ...
- San Angelo Standard-Times,
The politics of a pill Nov 18, 2005
...get a prescription in time. The FDA should base its decisions on scientific findings about a drug's safety. Instead, in this case ...
- Fort Wayne News Sentinel,
Phase Forward wordt 'CDISC Registered Solution Provider' Nov 7, 2005
7, 2005--Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that it has ...
- Netherlands Corporate News,
Health & Medicine Nov 19, 2005
But a study published last week in the journal Pharmacoepidemiology and Drug Safety found that doctors frequently don't heed the drug makers' guidance. ...
- U.S. News & World Report
Drug Tests Jeopardize Patients; FDA Must Do More, Grassley Says Nov 3, 2005
Grassley last year began an investigation of the FDA's handling of drug-safety issues after the withdrawal of Merck & Co.'s Vioxx painkiller. ...
- Bloomberg
InforMedix CEO Named Chairman of the Board of the Institute on ... Nov 18, 2005
...companies, and medical researchers to efficiently monitor and manage patients' medication and care plan adherence, clinical response, and drug safety. ...
- PharmaLive.com (press release),
Federal Vioxx plaintiffs challenge Merck's "18-month myth" Nov 16, 2005
HOUSTON Plantiffs lawyers say whether Vioxx can be lethal if taken for just a few weeks will be the crux of the first federal trial on the drug's safety. ...
- KLTV,
Govt Flu Plans Assailed as Inadequate, Pro-corporate Nov 11, 2005
...the public, recent federal initiatives would fail to resolve shortages of medical resources, encourage corporate profiteering and flout drug-safety regulations ...
- The NewStandard,
Sophion deal aims to expand into Japanese market Nov 10, 2005
...technical support for QPatch systems, while first hand application support will be provided in a non-profit collaboration with Drug Safety Testing Centre (DSTC ...
- Drug Researcher.com,
FibroGen Appoints Russell H. Ellison, MD, MSc, Vice President of ... Nov 10, 2005
...brings over 26 years of pharmaceutical industry experience in the leadership of clinical development, medical and regulatory affairs, and drug safety functions ...
- PharmaLive.com (press release),
Biotechnology Can Transform Medicine, Health Care, Expert Says Oct 27, 2005
...believe, the refinement of “targeted therapies� aimed at the biological underpinnings of disease should dramatically improve drug safety and efficacy ...
- Washington File,
Leader: Pharmas reveal their eagerness to please Nov 17, 2005
...behaviour. Drug safety scandals – such as over Vioxx and Seroxat – have invited the media to portray 'Big Pharma' as a pariah. ...
- PRWeek (subscription),
Hepatitis Combination Therapy Okay for Children: Study Nov 15, 2005
The first involved research to look for the most optimal dose of ribavirin added to this therapy, while also studying the drug's safety and efficacy. ...
- Hepatitis Neighborhood,
Equipment Understanding for Solid Dose Operators Provides the ... Nov 8, 2005
A brief introduction to the pharmaceutical production area, the role of production operators, and the importance of drug safety. Introduction to milling. ...
- Business Wire (press release),
Sophion Expands Into Japanese Market Nov 9, 2005
QPatch systems, while customer demonstrations and first hand application support will be provided in a non-profit collaboration with Drug Safety Testing Center ...
- PharmaLive.com (press release),
Laurels and darts Nov 10, 2005
Pharmaceuticals, Inc. says it will perform a final trial on the drug's safety and efficacy in January, for a projected release in 2007. For ...
- Daily Targum (subscription),
CREDIT: MARGARET N. OECHSLI Oct 29, 2005
Medicine monitor. A Food and Drug Administration (FDA) insider has been named the new director of the agency's Office of Drug Safety. ...
- Science Magazine (subscription)
Reforms Of EU Pharmaceutical Legislation Enter Into Force Nov 15, 2005
...granting of market authorizations for medicinal products, including for traditional herbal medicines, and new, stricter pharmacovigilance (drug safety) rules. ...
- Mondaq News Alerts,
Drug safety: RP’s neglected health frontier? 03 Oct 2005
ADRs. Pharmaceutical industry must address drug safety issues of their products by complying with safety monitoring requirements. ...
- Manila Bulletin
Brownie does his duty by raising curtain on cronyism 03 Oct 2005
At the Food and Drug Administration, scientists' decisions about drug safety are being scrutinized by a 33-year-old Bush backer whose most recent job was ...
- Macomb Daily
FDA Selects Ingenix for Drug Safety Monitoring and Support Sep 29, 2005
...are pleased to provide our extensive data resources and analytic capabilities to help the FDA respond to the urgent need for improved drug safety," said Terri ...
- dBusinessNews Newark (press release)
Ministry to tighten safety on kimchi Sep 30, 2005
The Food and Drug Safety Administration and the ruling Uri Party yesterday decided to establish a set of measures including a permissible level of heavy metal ...
- Korea Herald (subscription)
FDA turns to industry to help track drug safety, effectiveness Sep 28, 2005
The FDA can use the information in those files, which protect the privacy of patients, to conduct drug safety analyses in a proactive manner and "respond ...
- Minneapolis Star Tribune (subscription)
FDA Selects Ingenix for Drug Safety Monitoring and Support Sep 28, 2005
We are pleased to provide our extensive data resources andanalytic capabilities to help the FDA respond to the urgent need forimproved drug safety," said Terri ...
- Finanzen.net
Be aware of drug safety Sep 20, 2005
And all the possible pills that may come to your aid in the coming years, for chronic conditions you're likely to develop. With ...
- Fort Wayne News Sentinel
NO LINK BETWEEN DRUG SAFETY AND APPROVAL SPEED Sep 21, 2005
Given rising public concern over drug safety and assertions by FDA critics that drug safety in the United States has deteriorated since the adoption of user ...
- National Center for Policy Analysis
Canadian Drug Safety Sep 23, 2005
Choosing between medicine and rent. It's a dilemma that has some people turning to the internet to buy cheaper drugs from Canada. ...
- KVBC
Conference on post-market drug safety and effectiveness Sep 12, 2005
Improving the evaluation of post-market drug safety and effectiveness is an important element of the National Pharmaceuticals Strategy, an initiative First ...
- CNW Telbec (Communiqués de presse)
No Link Between Drug Safety in US and Approval Speed, According to ... Sep 7, 2005
The study, highlights of which were released today, failed to establish a link between FDA approval times and drug safety, said Tufts CSDD Director Kenneth I ...
- Business Wire (press release)
Free drug safety net's snags draw complaints Sep 4, 2005
By ANITA WADHWANI. The state is paying a Missouri company $11.4 million to provide a TennCare "safety-net" drug program that doctors ...
- The Tennessean
Politics not best criteria for drug safety Sep 5, 2005
If you're an American woman or care about the health of women you know, you rely on the FDA and people like Dr. Susan Wood, a woman you've probably never heard ...
- eTaiwan News
GlaxoSmithKline Manufacturing Problems Show Problem of Drug Safety ... Sep 14, 2005
..."GlaxoSmithKline's problems remind us that the answer to drug safety and efficacy lies in proper FDA oversight of the manufacture of pharmaceuticals, not the ...
- PR Newswire (press release)
Loopholes highlighted in drug safety checks Sep 11, 2005
The nation's health authorities have come under fire after a series of incidents have highlighted loopholes in the safety management of pharmaceutical products ...
- Korea Herald (subscription)
Safety Biomarkers Help to Reduce Drug Attrition Sep 13, 2005
Now the question is what can we do to encourage the application of genomic biomarkers for preclinical drug safety assessment?" In March the FDA issued a final ...
- Drug Discovery & Development (subscription)
Phase Forward completes drug safety data tool for FDA Sep 9, 2005
Research and Development Agreement (CRADA) with the US Food and Drug Administration to develop advanced analytical tools for drug safety risk assessment. ...
- Boston Mass High Tech
Tufts center finds no link between drug safety, approval speed Sep 12, 2005
Tufts CSDD director Kenneth Kaitin reports the center has found no evidence that links the rate of drug safety withdrawals and the passage of legislation more ...
- Boston Mass High Tech
Drug safety -- regulation or rigid prohibition? Sep 9, 2005
I cried when I read about 13-year-old Mercedes-Rae Clarke, who died, presumably, from adulterated drugs bought on the street. We ...
- Vancouver Province (subscription)
Four Groups To Help FDA Monitor Medication Safety, Effectiveness Sep 29, 2005
Calif.; Nashville-based Vanderbilt University; and Harvard Pilgrim Health Care of Wellesley, Mass., will work with FDA to monitor drug safety and effectiveness ...
- Kaiser network.org
Health Wrap: Suicide and side effects Sep 30, 2005
FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues, and will provide emerging information to health ...
- United Press International
New Jersey business briefs Sep 30, 2005
BASKING RIDGE - Basking Ridge-based i3 Drug Safety said Thursday it will help lead a Food and Drug Administration program designed to monitor the safety of new ...
- NorthJersey.com
Updated safety information on CELEBREX* (celecoxib) Sep 21, 2005
Drug Safety PO Box 800 Pointe-Claire- Dorval, Quebec H9R 4V2 1 800 463-6001 Any suspected adverse reaction can also be reported to: Canadian Adverse Drug ...
- Canada NewsWire (press release)
National Press Club Sep 28, 2005
And that is why we need the help of healthcare professionals and others who collect the kinds of drug safety reports that we use to uncover new potential risks ...
- FDA.gov
Health Canada: Conference on Post-market Drug Safety and ... Sep 14, 2005
Improving the evaluation of post-market drug safety and effectiveness is an important element of the National Pharmaceuticals Strategy, an initiative First ...
- PharmaLive.com (press release)
Phase Forward Announces Director Resignation Sep 30, 2005
Phase Forward Incorporated (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced today that Franklyn A ...
- Genetic Engineering News
Inhaled insulin gets safety check Sep 8, 2005
The review takes place amid drug-safety controversies stemming from last fall's Vioxx recall because of cardiac risks that became apparent years after it ...
- Miami Herald
A concern that drug companies cannot ignore Sep 30, 2005
I therefore suspect that the Committee's calls for reforming the MHRA will be resisted unless a major drug safety scandal forces action. ...
- Journal of the Royal Society of Medicine
FDA commissioner Crawford resigns Sep 25, 2005
...as the Agriculture Department and as an adviser to the World Health Organization, cited among his accomplishments new steps to improve drug safety and speed ...
- 9NEWS.com
Cure for a sick system: Simple steps would wrest power from a ... Oct 1, 2005
...served by having the drug companies literally paying more than half of the budget of the division of the FDA that approves new drugs and oversees drug safety. ...
- Boston Herald
Phase Forward Named to Deloitte's New England Technology Fast 50 Sep 26, 2005
26, 2005 -- Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that it has been ...
- TMCnet (press release)
Phase Forward Named to Deloitte's New England Technology Fast 50 Sep 26, 2005
WIRE)--Sep 26, 2005 - Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that ...
- PharmaLive.com (press release)
[EDITORIAL]Chinese kimchi scare Sep 29, 2005
Hurriedly, the hazards information team at the Food and Drug Safety Administration compared the Seoul City figures to the WHO's provisional tolerable weekly ...
- Korea Herald (subscription)
Mikulski Calls Head of FDA "Incompetent"; Expresses Concern Over ... Sep 22, 2005
FDA has always been the gold standard in maintaining drug safety and drug efficacy. Yet today, this agency is being politicized and degraded. ...
- Southern Maryland Online
Cutting Edge Information Reports on Pharmaceutical Business ... Sep 30, 2005
...invested heavily in a thought leader program which allowed it to make a strong connection with the medical community to ease fears about the drug's safety.
- B-EYE-Network
FDA Chief Quits; Tenure Marked By Turmoil Sep 25, 2005
Dr. Jerry Avorn, a Harvard Medical School professor of medicine and critic of the agency's handling of drug safety controversies, said the commissioner defines ...
- RedNova.com
Phase Forward's Safety Data Mining Solution in Production At FDA ... Sep 8, 2005
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the successful completion of ...
- Genetic Engineering News
Australian troops claim drug side effects Sep 29, 2005
...drugs.". The Pentagon is doing its own study on malaria drugs after concerns raised in Congress and elsewhere about the drug's safety. ...
- United Press International
FDA Issues Public Health Advisory on Strattera (Atomoxetine) for ... Sep 30, 2005
..."FDA's action today is another example of the agency acting swiftly to alert the public to significant drug safety information needed to use a drug in a safe ...
- Food Consumer
Cancer expert to take over FDA post Sep 23, 2005
Some of the research involved big drug safety controversies, such as a report showing increased suicidal behaviours in children taking anti-depressants, and ...
- MSN Money
FDA commissioner quits unexpectedly after rocky 2-month tenure Sep 24, 2005
Both issues made Crawford a lightning rod for criticism from lawmakers, drug safety advocates and women's rights activists during his tenure as interim, then ...
- San Jose Mercury News
FDA commissioner quits Sep 24, 2005
Both issues made Crawford a lightning rod for criticism from lawmakers, drug-safety advocates and women's rights activists during his tenure as interim, then ...
- Myrtle Beach Sun News
Phase Forward Acquires Lincoln Technologies Sep 22, 2005
By Mark D. Uehling, Bio-IT World. Last month, Phase Forward bought drug safety specialist Lincoln Technologies. This is the most ...
- Bio-IT World
Genentech: trial suspension unlikely to harm Avastin's progress Sep 26, 2005
However, given the current climate of sensitivity towards drug safety and the slight fall in its share price immediately following the study suspension ...
- Pharmaceutical Business Review
NEW REPORT ON EUROPEAN PHARMACEUTICAL MARKETING ELIMINATES ... Sep 28, 2005
...invested heavily in a thought leader program which allowed it to make a strong connection with the medical community to ease fears about the drug's safety. ...
- ITNews
Anorectics on Trial: A Half Century of Federal Regulation of ... Sep 6, 2005
Drug, and Cosmetic Act (1). Under this law, manufacturers had to provide the Food and Drug Administration (FDA) with evidence of a drug's safety before it was ...
- Annals of Internal Medicine
Rep. Hinchey, Colleagues Call For Federal Investigation Into ... Sep 29, 2005
...the drug industry and the FDA, eliminate conflicts of interest on FDA advisory committees, and vastly improve the agency's post-market drug safety operations. ...
- PharmaLive.com (press release)
FDA Revamps Prescription Labels Sep 29, 2005
..."This is an important step toward creating an electronic environment for drug safety and drug effectiveness information that will make it easier for doctors ...
- All Headline News
A critique of the press by a veteran reporter Sep 17, 2005
Perhaps the most mealy-mouthed description of all appeared last November in a Washington Post story on new government drug-safety initiatives. ...
- Nieman Watchdog
Merck's ex research big in Vioxx "agony" Sep 21, 2005
Frederick Humeston, a Vioxx user who blames the painkiller for his 2001 heart attack, about e-mails he wrote confessing his concerns about the drug's safety. ...
- CNN
FDA's Crawford Resigns as Top US Drug Regulator (Update2) Sep 23, 2005
23 (Bloomberg) -- Lester Crawford resigned as chief of the US Food and Drug Administration after three years of controversies over drug safety, animal feed ...
- Bloomberg
Drug to Test FDA's Risk Tolerance After Vioxx Sep 8, 2005
The review is taking place amid controversies about drug safety stemming from last fall's recall of Vioxx because of cardiac risks that became apparent years ...
- Los Angeles Times
Former FDA Chief Denies Financial Conflicts Sep 28, 2005
Crawford's tenure has been marked by controversy, extending not only to issues of reproductive health but also drug safety, including the firestorm that ...
- Forbes
Tripping Over Regulatory Hurdles Sep 28, 2005
...with the FDA on Tuesday, Incyte announced that it's being required to conduct another Phase II clinical trial to demonstrate the drug's safety and effectiveness ...
- Smartmoney.com (subscription)
Cancer institute chief sanguine on new role Sep 27, 2005
...said. Crawford's resignation came at a delicate time because the agency has been under fire because of its oversight of drug safety.
- Contra Costa Times
FDA official defends double appointment Sep 28, 2005
Gottlieb said the FDA`s ongoing moves to revamp the way the agency acts on drug-safety issues will not be affected by the agency`s current leadership situation ...
- Monsters and Critics.com
Who Should Be the New FDA Chief? Sep 26, 2005
So much for Long Live the King. The FDA has always had a difficult-to-balance mission. It is a safeguarding agency ensuring drug safety and efficacy. ...
- Bio-IT World
FDA Seeks Your Input on Morning-After Pill Sep 28, 2005
Medical Association and one of the FDA's own senior safety scientists recently publicly stated their grievous concerns about the FDA and its drug safety process ...
- ProLife Blogs
FDA Commissioner Lester Crawford Resigns Sep 23, 2005
Crawford, who had worked at the agency on four separate occasions over 30 years, cited among his accomplishments new steps to improve drug safety, efforts to ...
- San Francisco Chronicle
FDA commissioner steps down Sep 23, 2005
Crawford, who had worked at the FDA on four occasions over 30 years, cited among his accomplishments new steps to improve drug safety and speed drug development ...
- Minneapolis Star Tribune (subscription)
Leader of the FDA Steps Down After a Short, Turbulent Tenure Sep 24, 2005
...wanted on Plan B.". Under Dr. Crawford, the agency was buffeted by fierce debates over drug safety. Critics, including many in Congress ...
- Wilmington Morning Star
Andrew von Eschenbach Appointed New Acting Head of FDA Sep 26, 2005
Because he served as acting or deputy commissioner during the past five years, Crawford could not escape responsibility for the drug-safety issues in the Vioxx ...
- PharmExec.com
FDA rejects Pfizer's Oporia Sep 19, 2005
In the wake of recent drug safety scares, such as COX-II inhibitors on cardiovascular outcomes and hormone therapy on breast cancer after the WHI study, the ...
- Pharmaceutical Business Review
Drug prescriptions lethal to Americans Sep 11, 2005
...and 160,000 heart attacks since its approval by the FDA in May 1999, according to Dr. David Graham, an associate director of the FDA's Office of Drug Safety. ...
- Daily Aztec
Fears of 'overcaution' by FDA after Vioxx woes go unfounded Sep 21, 2005
Merck & Co.'s decision to pull the painkiller Vioxx triggered congressional hearings and a flurry of proposed bills designed to improve drug safety. ...
- Boston Globe
Incyte tumbles on HIV drug delay Sep 28, 2005
In a release, Incyte said the FDA has asked the company to conduct another Phase II clinical trial to show the drug's safety and effectiveness in treating HIV ...
- MarketWatch
Alba starts human testing of Celiac treatment drug Sep 27, 2005
...establishment of our clinical pipeline.". Phase I studies are generally used to determine a drug's safety. Subsequent studies will be ...
- Baltimore Business Journal
Pennsylvania pharmacist wins $500,000 'genius grant' Sep 20, 2005
Cohen said yesterday that he hasn't decided how he will spend the money, "but it will definitely be used toward something in the area of drug safety.". ...
- Pittsburgh Post Gazette
People on the Move Sep 21, 2005
Pharmaceuticals Inc. (inspirepharm.com). Dr. Smiley was senior VP, regulatory affairs, compliance, and drug safety, Trimeris Inc. John J ...
- R&D Directions (subscription)
Washington Report: Crawford Steps Up Sep 2, 2005
Probably the most important item on Crawford's agenda is to show that FDA can identify, prevent, and manage drug safety problems. ...
- PharmExec.com
The RADAR Project and the FDA Sep 13, 2005
...minimization efforts for patients and clinicians. Such information sharing is vital for continued drug safety and public health.
- Journal of American Medical Association (subscription)
- By Our Special Correspondent Sep 7, 2005
The study, highlights of which were released on Wednesday, failed to establish a link between FDA approval times and drug safety, said Tufts CSDD director ...
- The Asian Age
FDA Panel OKs Inhaled Insulin Drug Sep 9, 2005
...typically does. Wall Street was watching the panel review for signs that the FDA was becoming more conservative about drug safety. The ...
- Los Angeles Times
Plan B becoming a primary course of action Sep 21, 2005
...effects," Berrien said. This past statistical safety is what Berrien refers to as the drug's "safety profile.". Over-the-counter ...
- The Northeastern News (subscription)
Crawford resigns as FDA Commissioner Sep 26, 2005
...permanent post and subsequent tenure has been dogged by persistent criticism on issues such as the FDA's recent record on monitoring drug safety – a debate ...
- in-PharmaTechnologist
NeoPharm, Inc. Updates Phase I/II Median Survival Data and PRECISE ... Sep 27, 2005
It is designed to compare overall survival, drug safety and quality of life of patients receiving cintredekin besudotox with patients receiving GLIADEL(R ...
- Business Wire (press release)
Ex-Merck official says doctors not shown Vioxx data Sep 27, 2005
Merck hid Vioxx's risks in an effort to preserve its blockbuster sales and that the Alzheimer's studies should have raised red flags about the drug's safety. ...
- Reuters
Here's a thought: Reduce demand Sep 27, 2005
The FDA has been besieged by criticism for its recent record on drug safety, the pace of its drug and medical-device approval process and allegations from ...
- The Hill
Inhaled insulin gets green light from FDA panel Sep 9, 2005
...means assured. The companies have agreed to carry out long-term follow-up studies, out to 2019, to monitor the drug's safety. In ...
- in-PharmaTechnologist
US advisers back Celgene blood disorder drug Sep 14, 2005
..."It's hard to approve a drug when you don't know the dose and you really can't provide direction as to the drug's safety," Raymond said. ...
- Reuters.uk
Bush's Choice for FDA Chief to Keep Other Job Sep 24, 2005
Scientists say the selection of Dr. von Eschenbach comes at a time when the pendulum at the FDA has swung toward an emphasis on drug safety. ...
- New York Times
NovaDel Pharma Inc. Announces Management Addition Sep 28, 2005
...proprietary oral spray technology delivery system offers the patient the potential for (i) fast onset of action; (ii) improved drug safety by reducing the ...
- Business Wire (press release)
Drama heating up in Merck Vioxx trial Sep 19, 2005
...exhibits, Seeger pointed out that Merck officials knew of the dangers, but because Vioxx was considered a potential blockbuster drug, safety precautions were ...
- The Trentonian
FDA Head Crawford Abruptly Resigns Sep 23, 2005
Last year's recall of Vioxx, a painkiller, revealed flaws in the agency's oversight of drug safety and prompted criticism it had grown too cozy with the ...
- Los Angeles Times
Study: New Antipsychotic Drugs No Better Than Older Ones Sep 20, 2005
FDA is not doing its job. “We really only seriously test drug safety on the vast public,? she said. That is not right.?.
- TheDay (subscription)
US FDA Commissioner Lester Crawford resigns Sep 23, 2005
...becoming permanent FDA chief. The FDA faced a string of drug safety controversies during Crawford's tenure. Some critics charged ...
- Reuters
2ND UPDATE: FDA Commissioner Crawford Resigns Sep 23, 2005
...and Drug Administration Commissioner Dr. Lester Crawford resigned Friday amid complaints his agency has repeatedly dropped the ball on drug safety and played ...
- Business Online
FDA Commissioner Lester Crawford resigns Sep 23, 2005
...on Friday after a bruising fight over whether the agency would approve over-the-counter sales of a morning-after pill and a string of drug-safety controversies ...
- ABC News
Dr. Throckmorton Appointed Deputy Director of FDAps Center for ... Sep 22, 2005
...broad national and international activities in drug regulation, Dr. Throckmorton will continue to be the founding chair of FDA's new Drug Safety Oversight Board ...
- FDA.gov
New FDA Chief Resigns Sep 24, 2005
Crawford has had a stormy tenure at the agency, which has been beset by criticism from both left and right over its actions regarding drug safety and emergency ...
- Hartford Courant
Pfizer Wins Panel Backing for First Inhaled Insulin (Update4) Sep 8, 2005
Analysts including National City Private Client Group's John Farrall in New York said the meetings may provide a gauge of the agency's stance on drug safety. ...
- Bloomberg
Clinical research firm shops around Sep 20, 2005
With the Food and Drug Administration taking criticism recently for how it has handled the Vioxx debacle and other drug-safety issues, Garrett believes that ...
- Washington Business Journal
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