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MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds

08 Jul 2021

In newly published meeting minutes, industry and the US FDA continued to clash over a proposal to create a new pre-submission advisory program and what to do with carryover user-fee funds.

Close-up Of two businesspeople arm wrestling

Medtech industry representatives want an audit of the US Food and Drug Administration’s user-fee finances and say their members are against implementing a pre-submission program that would include external stakeholders such as payers.

Industry and FDA representatives met for the fourth time on 28 April to negotiate over the Medical Device User Fee Amendments (MDUFA V) deal that is expected to go into...