FDA Draft Guidance Calls for Early Correspondence to Speed ANDA Review

The FDA is proposing to shorten ANDA review timelines for certain generics sponsors that submit advance information to the agency.

PFCs are one of several enhancements specified by the GDUFA II commitment letter to streamline the review process for priority ANDAs. In the commitment letter, the FDA pledged to review 90 percent of priority review ANDA submissions in eight months as well as notifying generics makers of its decision on ANDAs within 60 days of submission.

PFCs must include a listing of all facilities involved in the manufacturing and testing process for the ANDA and corresponding API drug master file, as well as any facilities or organizations involved in bioequivalence and clinical studies used to support the ANDA submission. There must be no facility information changes in the ANDA. The PFC should also include a statement of ANDA eligibility for priority review. — Zack Budryk