Drug Maker Takes Issue With F.D.A. Panel
235328
Sanofi-Aventis said it planned additional discussions with the F.D.A. after it was told that it should not continue marketing the antibiotic Ketek.
238665
Calls for changing the way the government monitors drug safety erupted Friday, as consumer advocates and worried patients zeroed in on testimony that five federally approved medicines posed significant health risks.
494061
BETHESDA, Md.  - A U.S. advisory panel on Friday  urged regulators to reject over-the-counter sales of Merck &  Co. Inc.'s MRK.N cholesterol-lowering drug Mevacor.
258753
WASHINGTON -- The Food and Drug Administration is preventing an agency scientist from presenting the largest, most up-to-date study of popular painkillers like Bextra, Celebrex and Vioxx during an FDA meeting next week on heart risks posed by the drugs, a US senator charged.
54539
WASHINGTON - The US pharmaceutical industry that exports billions of dollars worth of medicine around the world faced new scrutiny Friday after a survey revealed nearly one-fifth of its government overseers had experienced pressure to approve drugs they
303288
The move comes after months of criticism that the F.D.A. was too slow to react to reports linking Vioxx and Celebrex to increased risks.
687262
A U.S. advisory panel on Friday urged regulators to reject over-the-counter sales of Merck & Co. Inc.'s  cholesterol-lowering drug Mevacor.
31204
The story of COX-2 drugs is an example of how difficult it is for the F.D.A. to monitor the safety of drugs after they have been approved for the market.
310850
The board, which met this weekend, reportedly expressed concern about regulatory scrutiny.
226541
A leading doctor expressed concerns about the heart risks of GlaxoSmithKline Plc's diabetes drug Avandia in a letter to the U.S. Food and Drug Administration seven years ago.
521886
A Senate hearing about money and gifts that drug makers routinely provide to doctors did not go well for the drug industry Wednesday.
63282
The potential heart risks of GlaxoSmithKline Plc's diabetes drug Avandia are still not clear, the head of the U.S. Food and Drug Administration told lawmakers who questioned the agency's oversight of the widely used pill on Wednesday.
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
224422
New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the US federal Food and Drug Administration to protect Americans from such risks.
140672
WASHINGTON - The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday...
238158
Health care advocates, providers and FDA officials over the weekend &#39;sparred&#39; over alleged problems with the FDA prescription drug safety review process and the safety of five medications currently on the market, after an FDA safety reviewer on Thursday
193540
The US Food and Drug Administration yesterday sought to distance itself from remarks by one of its top safety officials that raised concerns about key drugs made by Astrazeneca and Glaxo Smithkline.