March 22, 2019pdufa

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A-List Of Speakers At Harvard

Post-Approval? Or Pre-Apocalypse?

April 08, 2008

Maybe it’s the medical school ambiance. Or the end of a long Boston winter. But every year, for mysterious reasons, the Post Approval Summit feels a bit different than other meetings. It’s a little cozier. More intimate. The conference is held in the spring in an auditorium at Harvard Medical School. It’s organized by a technology vendor, Outcome, which specializes in registries and post-marketing projects. The event runs on May 14-15. This is the registration page. The conviviality of the conference is a bit surprising, given an A-list of rock-star-worthy speakers plucked from the Rolodex of Richard Gliklich, Outcome’s president and CEO. He says the tone of the meeting is a reflection of the shared biographical paths of some of the speakers. “Many of them come from the same roots,” he says. “You have someone from industry who went to medical school with someone from the FDA.” Heavy Hitters So who’s…more...

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Gottlieb on FDA, Safety

Poking The Politicians

May 25, 2007

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…more...

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New Tools, More Trials?

Radical Drug Safety Shift

March 29, 2007

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…more...

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Fast-Track Status

Napo Proclaims Adaptive Design

March 20, 2007

ClinPage has drunk the Kool-Aid about adaptive designs. We think they could forever alter the timelines and budgets of entire portfolios of clinical trials. But there is hardly a technology we…more...

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Funds for IT, post-marketing, safety

FDA: Raise PDUFA Fees 29 Percent

January 15, 2007

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. By definition, of course, such fees would be charged to the industry. FDA is suggesting $87.4 million…more...

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