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Ex-HHS Aide Says Overton Pressured Makary Over Vaccine Approval
Former senior HHS adviser Calley Means has accused FDA commissioner nominee Heidi Overton of pressuring former commissioner Marty Makary to approve Moderna's mRNA influenza vaccine despite his scientific objections, alleging that she conditioned assistance on other policy matters on his willingness to approve the product. Means resigned 10/
Novocure Gets Rejection Letter on Lung Cancer Device
FDA has issued Novocure a Not Approvable Letter for its PMA for Optune Mya for treating adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation. The said the agency determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval, according
FDA Posts 18 Form 483 Inspection Records
FDA has posted 20 Form 483 inspection records (see below), including reports involving Novo Nordisk, AnaptysBio, Protagonist Therapeutics, Ascendis Pharma and Charles River Laboratories, as the agency continues expanding public access to inspection findings through its electronic reading room. Their availability is part of the agency’s expanded transparency initiative
New Congress’ Impact on FDA Leadership, User Fee Reauthorization: Analyst
Democratic control of Congress following the 11/3 midterm elections could bring increased oversight of FDA and HHS, complicate the nomination of a permanent FDA commissioner and turn the 2027 user fee reauthorization into a vehicle for broader health policy legislation, according to FDA policy analyst and former HHS official