With in­dus­try's bless­ing, FDA launch­es nov­el ex­cip­i­ent re­view pi­lot pro­gram

The FDA on Tues­day launched a new pi­lot pro­gram that will ini­tial­ly re­view four nov­el ex­cip­i­ents over two years, with an eye to­ward help­ing drug de­vel­op­ers in sit­u­a­tions where ex­ist­ing ex­cip­i­ents may be dif­fi­cult to em­ploy.

The plan for such a pi­lot has been in the works since at least 2019, as the FDA does not cur­rent­ly re­view new ex­cip­i­ents as part of an IND or a mar­ket­ing ap­pli­ca­tion, al­though some nov­el ex­cip­i­ents may pro­vide pub­lic health ben­e­fits, such as im­proved drug de­liv­ery or po­ten­tial­ly abuse-de­ter­rent prop­er­ties that could be key for new opi­oid for­mu­la­tions.

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