Legislation to create a pathway for FDA approval of generic biologics should be attached to the reauthorization of the Prescription Drug User Fee Act, Sen. Charles Schumer, D-N.Y., said at a Feb. 14 press conference announcing reintroduction of the bill
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Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
