PDU­FA VII: What's new, and what's sig­nif­i­cant in the next user fee deal

When PDU­FA VI ex­pires in Sep­tem­ber 2022, all eyes will be on the next five-year user fee deal, in­clud­ing what changes FDA has to make that are sig­nif­i­cant, new or mod­i­fied from past deals.

Those de­tails and more made their way in­to the Fed­er­al Reg­is­ter this morn­ing, along­side news of a half-day, pub­lic meet­ing on PDU­FA VII set for Sept. 28.

Tak­ing a step back, PDU­FA was orig­i­nal­ly en­act­ed in 1992 as a law that au­tho­rizes FDA to col­lect fees from drug com­pa­nies that sub­mit mar­ket­ing ap­pli­ca­tions for cer­tain drugs and bi­o­log­ics. The FDA agrees, in ex­change for those fees, to meet spe­cif­ic re­view time­lines for new drugs and sup­ple­ments.

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