Pink Sheet Podcast: Janet Woodcock And The US FDA’s G.O.A.T., Puberty Blockers Meeting, CAR-T Safety
Pink Sheet reporters and editor discuss FDA Principal Deputy Commissioner Janet Woodcock’s place in the pantheon of FDA leaders, an agency meeting with stakeholders on puberty blockers, and a new boxed warning for CAR-T therapies.
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Pulling the controversial Alzheimer’s drug’s BLA should not exempt Biogen from fulfilling ClinicalTrials.gov reporting requirements for two key studies, even if the research gets terminated, former head of the NIH data repository tells the Pink Sheet.
Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.
CMS Expects Part D Plans To Go To Great Lengths Facilitating Participation In New Copay ‘Smoothing’ Option
The Medicare draft guidance seems designed to ensure seniors don’t miss out on the IRA benefit.