In­dus­try, FDA be­gin to ham­mer out PDU­FA VII de­tails

Dis­cus­sions con­tin­ue be­tween in­dus­try and the FDA re­gard­ing the up­com­ing reau­tho­riza­tion of user fees for pre­scrip­tion drugs, bi­o­log­ics and gener­ic drugs. Af­ter pub­lic hear­ing and a first round of meet­ings that gave a peek in­to pri­or­i­ties for in­dus­try and reg­u­la­tor rep­re­sen­ta­tives, this next round be­gan to sort out some de­tail.

On Nov. 20 and Dec. 11, pub­lic stake­hold­er meet­ings were held on the Pre­scrip­tion Drug User Fee Amend­ments reau­tho­riza­tion (PDFUA VII) that will span the fis­cal years 2023-2027. Broad­ly, the Nov. 20 meet­ing pre­sent­ed in­for­ma­tion on FDA’s drug safe­ty sys­tem, which has been mod­ern­ized dur­ing PDU­FA VI. Par­tic­i­pants in the meet­ing dis­cussed “how FDA post-mar­ket process­es ad­dress health dis­par­i­ties and rep­re­sen­ta­tive­ness and how new in­for­ma­tion and ad­di­tion­al re­search af­fects FDA re­view of black box warn­ings,” ac­cord­ing to FDA’s record of the meet­ing.

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