FDA Review Should Be More Like Business Negotiation, Orexigen CEO Says
Having seen the “worst of ambiguity and then the greatest of clarity” from FDA, Mike Narachi concludes that “what’s lacking in the U.S. review process is leadership and decision-making that’s transparent to the sponsor.”
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The summary report of an interim analysis of the ongoing LIGHT clinical trial evaluating the cardiovascular safety of the obesity medicine can form the basis of a resubmission of the Contrave NDA, the company announced, shaving some time off the PDUFA clock.
Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.
Offering a regulatory Mt. Rushmore to place the outgoing principal deputy commissioner in historical context.