FDA Doubles Estimated Time Needed For DMF Completeness Assessment

FDA now says Type II active ingredient drug master files should be submitted six months before the referencing ANDA to allow enough time for the completeness assessment. Delays could mean refuse-to-receive action for the ANDA.

FDA has strongly recommended drug master files arrive much earlier than initial estimates to avoid delaying the referencing ANDA, likely requiring more extensive planning for sponsors and further complicating the review process for both submissions.

The agency now is suggesting Type II active pharmaceutical ingredient DMFs should be submitted at least six months before the...