Preap­proval and oth­er man­u­fac­tur­ing in­spec­tions: FDA re­vis­es two com­pli­ance guides

The FDA’s re­vi­sions of two com­pli­ance pro­grams — large­ly re­lat­ed to the in­tro new ICH work — deal with preap­proval and oth­er drug man­u­fac­tur­ing in­spec­tions and went in­to ef­fect to­day.

Ac­cord­ing to an FDA spokesper­son, the com­pli­ance pro­grams aim to pro­vide in­struc­tions to FDA staff for ob­tain­ing in­for­ma­tion from man­u­fac­tur­ers. Com­pa­nies can glean new in­for­ma­tion about what FDA wants from look­ing in­to the guides.

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