Trump 2.0

New terms of reference for the Advisory Committee on Immunization Practices’ overhauled work groups on influenza, HPV and RSV reflect some members' broader concerns about the potential long-term adverse effects of vaccination.

Two flu vaccine labels already include febrile seizure in the clinical trial and postmarketing experience sections of the label, but the FDA wants all of them to add a warning of the adverse event.

The FDA does not like the idea, in part because estimating annual revenue likely would be tougher.

“FDA’s proposed GRAS rule would move GRAS closer to the NDI model in at least one key respect, which is mandatory notification,” says attorney Ashish Talati. Proposed rule isn’t expected to require removal of ingredients available through self-GRAS processes.

The unusual revision of Corcept’s complete response letter suggests the FDA may be writing for a different audience now that unapproved product CRLs are being made public.

Pink Sheet editors discuss new information on the Commissioner’s National Priority Voucher Program, including the role of the center directors and the Commissioner’s National Priority Voucher Review Council in application reviews.

The French firm will always ‘defend with evidence’ the positive impact of vaccination, ‘irrespective of who is in office,’ the French firm’s CEO has declared.

The HHS OIG advisory pertains to manufacturer sales to patients. OIG will seek stakeholder input regarding possible additional guidance on manufacturer arrangements with pharmacies, pharmacy benefit managers, telemedicine vendors and marketers.

Sponsors also want efficacy supplement action packages released after redaction as part of a proposal to increase first-cycle approvals.

Changing self-GRAS regulation, providing NDIN safety and identity guidance and modernizing supplement industry regulatory framework are on FDA’s “2026 priority deliverables,” but not requirement for public listing of all supplements available.

ARS Pharmaceutical and Altor BioScience received second untitled letters for identical or similar promotional claims that the agency flagged as violative in its September enforcement blitz.

Enactment of a law delinking PBM compensation from list prices would still be a long-sought victory for pharma.