FDA releases draft guidance to assist applicants preparing to submit ANDAs

The US Food and Drug Administration (FDA) has released draft guidance to assist applicants preparing to submit abbreviated new drug applications (ANDAs) to the FDA. The draft guidance highlights common, recurring deficiencies that may result in a delay in the approval of an ANDA. Recommendations are made to applicants on how to avoid these deficiencies with the aim of reducing the number of review cycles necessary for approval. In addition to discussing patent and exclusivity deficiencies, the draft discusses labelling, product quality and bioequivalence deficiencies.

Multiple review cycles has been an outstanding challenge for the FDA, with less than 10% of ANDAs gaining approval in the first review cycle. Multiple review cycles are costly and inefficient. On average it takes four cycles for an ANDA to reach approval due to factors such as the application missing the necessary information in order to demonstrate that the product meets the FDA standards.

The FDA is looking to prioritise their review of ANDAs for branded drugs with three or less competitors and help companies understand why their ANDAs are deficient.

To view the draft guidance on good ANDA submission practices, please click here.