PDU­FA VII ne­go­ti­a­tions near fin­ish line with plans to re­vamp CBER and staff up

Ne­go­ti­a­tions for the next Pre­scrip­tion Drug User Fee Act (PDU­FA VII) are ap­proach­ing their end as both FDA and bio­phar­ma in­dus­try reps agreed in their last steer­ing com­mit­tee meet­ing in mid-Feb­ru­ary to re­solve any out­stand­ing is­sues with the gen­er­al­ly agreed-up­on com­mit­ment let­ter, pro­posed statu­to­ry changes, and statu­to­ry jus­ti­fi­ca­tions via email.

The ne­go­ti­a­tions de­cide how the FDA will use in­dus­try’s hun­dreds of mil­lions of dol­lars in fees from 2023 to 2027, and what, in ad­di­tion to the time­ly re­views, the bio­phar­ma in­dus­try will re­ceive for its pay­ments.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER