Janet Woodcock news from FiercePharma
News
Stupak: FDA needs subpoena power
Rep. Bart Stupak might be a severe FDA critic, but he's also shaping up to be the agency's dearest friend. Chief of the House Energy and Commerce committee's oversight-and-investigations group,
Read more...Public Citizen joins FDA review
When Cephalon asked the FDA to expand the use of its opioid painkiller Fentora, did it see the shape of things to come at the Read more...
FDA backpedals on inspection funding
Now you see it, now you don't. Congress thought--or pretended to think, you never know on Capitol Hill--that the FDA had ball-parked the funding it needs to beef up foreign inspections. That would Read more...
FDA wants power to police imports
The FDA finally put its mouth where the money is. During congressional hearings yesterday, CDER chief Read more...
FDA: Drugmakers responsible for safety
Congress may be all fired up about funding more foreign inspections by the FDA, but the agency itself? Not so much. In Read more...
FDA to piggyback on insurers' databases
Remember that drug-safety database Congress required the FDA to set up? The idea was for the FDA to actively monitor drugs and possible adverse effects, rather than waiting for doctors and drug Read more...
Study: Last-minute drugs less safe
When FDA reviewers cram, do they perform poorly on the test? A new study concludes that yes, when drugs are approved right on deadline, they're more likely to cause safety problems later. The Harvard Read more...
ALSO NOTED: Pre-emption fears helped spur Zyprexa deal; U.K. implant makers charge U.S. market;
> Scratching your head over the Zyprexa settlement in Alaska? Apparently, the prospect of a Supreme Court ruling that might sweep away state pharma suits helped spur the agreement. Read more...
FDA chief: Woodcock is a 'change agent'
No, says Andrew von Eschenbach, it's not business-as-usual at the FDA. A thousand times no. The agency commish got peeved during an appearance at the American Enterprise Institute when someone Read more...
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