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FDA Returns To MDUFA Table With High, Low Proposals

The priorities-gap between FDA and industry in MDUFA IV negotiations is narrowing. In May, the agency returned with counter-proposals that reduce user-fee increases compared to its prior plans, though there is still at least a $160m difference from the most recent proposal that is public from industry.

The most recent Medical Device User Fee Act negotiation meeting minutes posted by FDA suggest that regulators and industry are getting closer to agreeing on components of a MDUFA IV proposal. Returning to the negotiating table on May 16, the agency presented two proposals to industry that are approximately $30m apart.

During the meeting last month, FDA presented a proposal that that would raise $680 million plus inflation through device user...

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