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New Fundings And Goals To Match Raised In Latest MDUFA IV Session

This article was originally published in The Gray Sheet

Executive Summary

As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.

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