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FDA, Industry Agree On Working Groups To Support User-Fee Negotiations

The agency and industry agreed to create working groups allowing subject-matter experts to delve deeper into technical details on some of the key proposals raised thus far in user-fee reauthorization talks. Areas of focus include de novo reviews, pre-submissions and personnel recruitment challenges.

FDA and industry representatives say they plan to establish specialized working groups to address several key issues that have come up during MDUFA IV user-fee negotiations, highlighting topics ripe for substantive reforms as part of user-fee reauthorization.

The parties agreed to the working groups, which will be made up of subject-matter experts, at a user-fee negotiation meeting in December, according to meeting minutes posted by...

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