Pharmaceutical manufacturers argued FDA can’t make them report quality metrics data, but there was little else they could agree on in their initial reaction to the complex, enforceable reporting scheme FDA has proposed in its draft quality metrics guidance.
Industry’s anxieties about the pharmaceutical quality metrics guidance FDA drafted in July boiled over in an Aug. 24 meeting at FDA’s Silver Spring, Md., headquarters.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.
All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote
Wide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions.
Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.
