FDA Issues Draft Guidance, Updates Staff Manual to Speed ANDA Reviews

In a move aimed at speeding reviews of generics this year, the FDA released a new draft guidance on ANDAs for public comment along with an updated Manual of Policies and Procedures (MAPP) for agency staff that went into immediate effect.

The guidance highlights common, repeated deficiencies that can slow the approval process for ANDAs. Major deficiencies fall into the categories of patents, labeling, quality and bioequivalence.

ANDAs sometimes fail to include required patent information. Applications need to include all patent information for a reference listed drug in the FDA’s Orange Book, the agency said.