Report Assails F.D.A. Oversight of Clinical Trials
29543
The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
129855
Dr. David Graham, the Food and Drug Administration scientist who publicly criticized the agency&#39;s approach to drug safety during a congressional hearing last week, said
226044
U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc  and Schering-Plough's  cholesterol  medicine Vytorin following the drug's failure to work better  than a generic drug in a study of plaque build-up in neck  arteries.
6886
U.S. regulators said on Thursday they were reviewing two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs sold by Amgen Inc and Johnson & Johnson.
379737
Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
671309
The U.S. Food and Drug Administration issued a new report on Tuesday describing potential risks of several medicines after criticism that it was lax in policing drugs once they were on the market.
161932
The problems with Vioxx, taken off the market last week, raise questions about the Food and Drug Administration's safety review process. Observers say longer clinical trials should be required.
336236
U.S. regulators said on Friday they would review a study showing a Merck and Schering-Plough cholesterol drug worked no better than a generic in preventing the build-up of arterial plaque.
250955
U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of the antibiotic Ketek (Sanofi-Aventis) and some other prescription drugs on Tuesday.
171919
U.S. regulators said on Friday they  would review whether to take action over Merck & Co Inc's   and Schering-Plough Corp's  popular cholesterol  medicine Vytorin after a study showed it was no better than a  generic drug in preventing the build-up of fatty plaque.
552741
U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of a Sanofi-Aventis antibiotic and some other prescription drugs on Tuesday.
458929
U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc and Schering-Plough's cholesterol medicine Vytorin  following the drug's failure to work better than a generic drug  in a study of plaque build-up in neck arteries.
532860
WASHINGTON -- The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
41829
The Food and Drug Administration of the US found itself in the midst of a rather unpleasant controversy. Recently the chief of Cleveland Clinic Foundationâs department of cardiovascular medicine blamed this
576668
Ina series of testy e-mail exchanges with his bosses, a federal drug-safety reviewer contends that an effort to publish his study demonstrating the dangers of Vioxx was delayed and demeaned
339236
A study aimed at showing whether a single dose of an AIDS drug could prevent mothers from passing the virus to their newborns was so sloppily run that it should be disregarded, a fired oversight expert said on Tuesday.
344028
Patients in trials of drug treatments are being left in the lurch when the research finishes, doctors say.