F.D.A. Widens Safety Reviews on New Drugs
106744
The F.D.A. plan is the latest effort to fix the agency after a series of missteps.
507272
Pfizer Inc. said Friday that it will provide health-care professionals with additional information about its Bextra arthritis drug and that it will conduct further studies to confirm the drug&#39;s long-term cardiovascular safety record.
415778
NEW YORK, December 24  - The Food &amp; Drug Administration (FDA) announced yesterday that it planned to examine the various studies that link the usage of several painkillers with heightened cardiovascular risks, while recommending that
231875
The US Food and Drug Administration (news - web sites) on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck &amp; Co.
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.
729539
WASHINGTON - The Food and Drug Administration yesterday gained broad new powers to ensure the safety of prescription drugs used by millions of Americans under a bill signed by President Bush.
294794
Scrutiny of other pain relievers urged over fear they, too, may lead to heart problems. By Marilynn Marchione. Momentum was growing for a fresh look at the safety of Celebrex and other pain relievers as key
454410
Editors of the world&#39;s leading medical journals said yesterday that drug companies should disclose more information about studies of new medicines.
38677
The world's biggest drug makers unveiled  plans on Thursday to publish more data about clinical trials of  their medicines in a bid to reassure patients about their  safety.
157316
A consumer group and 35 doctors and scientists asked the federal government Thursday to convene an independent review of the science that led to new guidelines urging wider use of cholesterol-lowering statin drugs.
343910
A veteran scientist at the Food and Drug Administration said yesterday he will present new, unpublished findings about heart risk associated with a number of pain drugs at a meeting to assess whether they are safe enough for patients.
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.
137354
The Food and Drug Administration announced Friday its intentions to conduct a major evaluation of its approach in dealing with safety concerns involving drugs, primarily those that are already marketed.
26961
Merck &amp; Co. said the US Food and Drug Administration has requested additional safety and efficacy information on its Vioxx successor, Arcoxia, before it considers granting US approval for the drug.
512837
Washington --- The Food and Drug Administration, accused in recent weeks of being cozy with the pharmaceutical industry, must open its practices to greater public scrutiny, says a top official of the agency&#39;s besieged Office of New Drugs.
266095
The pharmaceutical industry made a commitment Thursday to publish more data about clinical drug trials, amid growing questions about the safety of many leading companies' medicines.
603923
U.S. health officials on Thursday announced a new program to help pinpoint sooner what chemicals could make effective drugs as well as whether certain medicines work better in specific patients.