Pink Sheet Podcast: Off-Label Coms Guidance, Price Negotiations And Prescribing, Bertagnolli’s NIH Bid
Pink Sheet reporters and editors discuss new off-label use communications guidance, how price negotiations could impact prescribing, and Monica Bertagnolli’s nomination for NIH director advancing.
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Pink Sheet Podcast: Janet Woodcock Retiring, Accelerated Approval Reform, US FDA Meeting Recording Policy
Pink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches, the stance of the FDA’s oncology division on confirming benefit after an accelerated approval, and why formal meetings between the agency and sponsors cannot be recorded.
Pink Sheet Podcast: FTC Orange Book Patent Challenges, Ad/Promo Due Diligence, US FDA Adcomm Decision Appeal
Pink Sheet reporter and editors discuss the FTC’s challenges of Orange Book patents, DTC promotion practices as part of acquisition due diligence, and how Intarcia’s advisory committee decision appeal could play out.
Pink Sheet Podcast: Adcomm Rejects NurOwn For ALS, FDA In Shutdown Mode, Limited Price Negotiation Savings
Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug, the impact of a government shutdown on the agency, and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations.