MAPP - Generic Drug Labeling Revisions Under Section 505(j)(10) of the FFD& C Act

Section 3224 of the Federal Food, Drug, and Cosmetic Act amended section 505(j)(10) to broaden the scope of Reference Listed Drug (RLD) labeling revisions covered under this section. It extended the timeframe for certain approved changes from within 60 days of an Abbreviated New Drug Application (ANDA) becoming eligible for approval to within 90 days. Additionally, the amendment now requires ANDA sponsors to commit to submitting revised labeling within 60 days of ANDA approval, rather than upon FDA notification of labeling changes.