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August 22, 2008
Gottlieb on FDA, Safety
Poking The Politicians
Earlier this month, at BIO, we heard ex-FDA official Scott Gottlieb. He voiced concerns about FDA funding, internal dissent at the agency, and prejudice against primary care physicians.
New Tools, More Trials?
Radical Drug Safety Shift
Proposed legislation would profoundly alter the U.S. drug safety landscape.
Funds for IT, post-marketing, safety
FDA: Raise PDUFA Fees 29 Percent
The agency says $29 million of $87 million in proposed new spending would go toward 80 additional employees to monitor drug safety in the post-marketing arena.
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Former deputy FDA commissioner Scott Gottlieb left the agency not long ago, returning to the American Enterprise Institute (AEI). Since leaving FDA, the prolific Gottlieb has written a large number of essays and articles for a variety of publications. We’ve…
It’s impossible to predict how the PDUFA issue will play out this year. But the House bill 1561 has a number of interesting provisions. It was introduced last week by Henry Waxman and Edward Markey, two California Democrats and longtime…
FDA has released a plan for enhancing drug safety. To pay for it, the agency has proposed a 29 percent rise in spending for a renewal of the Prescription Drug User Fee Act (PDUFA), from $304 million to $393 million.…
