FDA offers clarity on post-warning letter meetings in new draft guidance

FDA on Fri­day pub­lished draft guid­ance lay­ing out its ap­proach to post-warn­ing let­ter meet­ings for gener­ic drug­mak­ers, in­clud­ing the cri­te­ria for grant­i­ng the meet­ings and rec­om­men­da­tions for what fa­cil­i­ties should in­clude in their meet­ing re­quests.

Un­der the GDU­FA III com­mit­ment let­ter, gener­ic drug man­u­fac­tur­ing fa­cil­i­ties can now re­quest a meet­ing with FDA of­fi­cials af­ter re­ceiv­ing a warn­ing let­ter to dis­cuss how the com­pa­ny will ad­dress the agency’s con­cerns. The draft guid­ance, which aims to help com­pa­nies bet­ter ad­dress man­u­fac­tur­ing de­fi­cien­cies, lays out how com­pa­nies can re­quest post-warn­ing let­ter meet­ings with FDA, how to sub­mit a com­plete meet­ing re­quest pack­age, and how FDA plans to con­duct the meet­ings.

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