FDA, Industry Haggle Over Price For New User Fee Deal

As of last month, FDA and industry were several hundred million dollars apart, according to recently released negotiation meeting minutes. And insiders suggest the two are still haggling over the total amount companies will need to shell out in the five-year user fee reauthorization.

FDA and device industry negotiators have zeroed in on what program improvements they’d like to see in the 2012 user fee pact, but a significant gap remains on how much the two parties believe industry should pay in the final agreement.

More from Regulation

More from Policy & Regulation

Draft FDA Reorganization Would Unite All Product Centers

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
• By 

The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.