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Compounding Draft Guidance May End Par's Suit Against US FDA

 
• By Brenda Sandburg

Par says FDA shouldn't have authorized a compounded version of Vasostrict, but parties have asked court to wait until March, when a guidance is expected that may resolve the company's concerns.

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The US FDA may resolve Endo Pharmaceuticals Inc.'s lawsuit challenging the agency's drug compounding policy through draft guidance set to be released in March.

The parties filed a Jan. 24 joint motion to stay the case until either March 30 or the occurrence...

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Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

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PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
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Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

More from Agency Leadership

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 
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PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
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Swissmedic Appoints Trivigno As New Agency Head From 2026

 
• By Anabel Costa-Ferreira

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.