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

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.

FDA is proposing that new funding be provided for de novo classification reviews and pre-submission consultations, among other reforms, as part of the next user fee program.

The agency met with industry representatives Nov. 18 in its third closed-door meeting of ongoing negotiations to reach agreement on MDUFA IV, which would start after the current user fee...

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