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Abuse-Deterrence Among New GDUFA Regulatory Science Priorities

 
• By Derrick Gingery

FDA says it will need tools to evaluate technologies designed to deter nasal abuse in generics.

Among FDA’s generic drug research priorities for this fiscal year will be ways to review potential abuse-deterrent formulations specifically targeting the nasal route.

It is a particularly timely focus for the agency as it continues pushing for scientific advances in the area and...

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ACIP Upheaval Leaves Merck & Co. In A Lurch

 
• By Jessica Merrill and Bridget Silverman

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.

‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By Sue Sutter

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.

US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By Sue Sutter

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.