FDA issues draft guidance for industry on ANDAs

Following a record year for generic drug approvals in 2017, the US Food and Drug Administration yesterday issued the draft guidance for industry “ Good ANDA Submission Practices,” which highlights common, recurring deficiencies in Abbreviated New Drug Applications (ANDAs) that may lead to a delay in the approval of an ANDA.

The guidance also provides recommendations on ways potential and current applicants can avoid these common deficiencies, which may reduce the number of review cycles necessary to meet ANDA approval requirements.

In addition, the FDA published a companion Manual of Policies and Procedures (MAPP 5241.3), “ Good ANDA Assessment Practices,” which outlines ANDA assessment practices for the FDA Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ).