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FDA, Industry To Miss MDUFA V Congressional Deadline; Insiders At Odds Over Future Of Deal

The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.

Businessman and businesswoman yelling at each other through megaphones across a gorge
• Source: Alamy

The US Food and Drug Administration and the medtech industry will miss a 15 January congressional deadline to send a user-fee deal to Congress for approval. Insiders with knowledge of the negotiations disagree, however, on how far apart the two sides are on reaching a deal.

Industry groups including AdvaMed, the Medical Device Manufacturers Association (MDMA) and the Medical Imaging and Technology Alliance (MITA) have yet been unable to reach an agreement with the FDA on...

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