1. Pink Sheet

PDUFA Acronym War Begins: Could Reauthorization Be Called Patient-UFA?

 
• By Michael Cipriano

For first time ever, the administration that negotiated a user fee agreement won’t be shepherding its reauthorization through Congress.

Capitol House

The surprise election of Donald Trump as president has disrupted planning for industry and patient advocates alike. Companies mostly seem to think that’s a good thing, but one area where they are hoping for strong continuity is in the user fee program.

Industry and advocates outlined the topics at stake for the upcoming renewal of the Prescription Drug User Fee Act (PDUFA)...

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• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

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• By Neena Brizmohun

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Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.