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October 10, 2008
'Absolutely overwhelming'
FDAAA Update At DIA
FDA’s Sandy Kweder painted a portrait of an agency straining to deliver on the many elements of FDAAA.
New Woodcock Role?
PhRMA Safety Surveillance Pilot
PhRMA hopes to assist FDA in a broader effort to detect safety signals.
New FDAAA Paperwork
New FDA Form 3674, Explained
The FDA’s new Form 3674 is an attestation that a trial has been registered in clinicaltrials.gov.
Three Ticking Clocks
Bayer Halts Trasylol Sales
With journal editors in charge of drug safety, the political system has failed the industry and the public.
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The Food and Drug Administration Amendment Act of 2007 (FDAAA) is vast. And overwhelming. At least one FDA official seems daunted by it, nine months after it became law. Take Sandra Kweder, deputy director of the FDA’s Office of New…
Just as the FDA has received the resources to make a major push into post-marketing drug-safety surveillance under the Food and Drug Administration Amendment Act (FDAAA), the Pharmaceutical Research and Manufacturers of America (PhRMA) says it’s doing the same thing.…
We know you’re restless for more information about Form 3674, that beguiling new requirement that the FDA is imposing upon those sponsoring clinical trials. We were itching to know more ourselves. We rang the FDA. Unfortunately, after the phone call,…
In another significant win for medical journal editors in their new role as regulators, Bayer suspended sales of anti-clotting drug Trasylol (aprotinin), which had been implicated in kidney failure, cardiovascular problems and mortality risk. The drug had approximately $135 million…
