ARTICLE SUMMARY:
The device industry’s MDUFA V financial proposal obtained by Market Pathways includes a small opening for FDA to pilot the TPLC Advisory Program, which the agency has championed as a “game changer,” using existing carryover funds. Overall, industry proposes modest fee increases. It awaits FDA’s counterproposal in what have been contentious negotiations.
The TPLC Advisory Program (TAP)—a new framework for sponsor engagement—is the centerpiece of FDA’s user fee reauthorization proposal but the device industry has remained strongly opposed to including it in a MDUFA V agreement. Now, according to an industry user fee proposal obtained by Market Pathways, trade groups appear willing to pilot the TAP program.
