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Generic User Fee Waivers Created In Draft House Bill, Breaking FDA-Industry Agreement

 
• By Derrick Gingery

FDA says it likely will oppose the provision because it would create more administrative complexity and increase fees paid by individual firms, but many provider and professional associations think waivers could help prevent and alleviate drug shortages.

A small provision in the proposed House user fee package that would allow generic drug user fee waivers runs counter to the technical agreement negotiated by the FDA and industry to create the program.

A group of provider and professional associations is already urging adoption of the provision, though, because they believe it could...

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Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
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US Pricing Reform: New Products Offer ‘On Ramp’ To Implementation, Lilly’s Ricks Says

 
• By Cathy Kelly

Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.

More from North America

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

 
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HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.