Rare dis­ease out­fit Ac­er fum­bles at FDA, re­ceiv­ing CRL due to lack of in­spec­tion readi­ness at pack­ag­ing man­u­fac­tur­er

It’s nev­er fun to re­ceive a CRL, but per­haps even less so when the re­jec­tion has to do with man­u­fac­tur­ing rather than the drug.

Rare dis­ease play­er Ac­er, along with Gene­va-based part­ner Re­lief Ther­a­peu­tics, un­veiled Tues­day that the FDA had is­sued the two a CRL for AC­ER-001, a drug can­di­date to treat urea cy­cle dis­or­ders. From the CRL, as re­port­ed by the com­pa­nies:

[The FDA’s] field in­ves­ti­ga­tor could not com­plete in­spec­tion of [Ac­er’s third-par­ty con­tract pack­ag­ing man­u­fac­tur­er], be­cause the fa­cil­i­ty was not ready for in­spec­tion. Sat­is­fac­to­ry in­spec­tion is re­quired be­fore [the NDA] may be ap­proved. Please no­ti­fy us in writ­ing when this fa­cil­i­ty is ready for in­spec­tion.

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