FDA to kick off CMC readi­ness pi­lot pro­gram next April

The FDA is ready for par­tic­i­pants to ap­ply to a pi­lot pro­gram that will kick off on April 1, 2023 around chem­istry, man­u­fac­tur­ing and con­trols (CMC) readi­ness.

The pi­lot project will help ex­pe­dite the CMC de­vel­op­ment of prod­ucts, which is an area where spon­sors fre­quent­ly run in­to is­sues and CRLs. The pi­lot fea­tures in­creased com­mu­ni­ca­tion be­tween FDA and spon­sors, with two ded­i­cat­ed CMC meet­ings, as well as ad­di­tion­al op­por­tu­ni­ties for spon­sors to ad­dress ques­tions aris­ing from the meet­ing or meet­ing min­utes, or if ad­di­tion­al clar­i­fi­ca­tions are need­ed.

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