Originally published on January 4, 2018, the Agency says it has finalized and revised the guidance document in response to “comments received on the draft guidance as the guidance was finalized and made minor edits and other editorial changes to improve clarity. Revisions include clarification of the recommendations pertaining to patent and exclusivity deficiencies, as well as those pertaining to product quality deficiencies relating to the drug substance. We have also clarified the recommendations relating to ANDAs that propose to use bioequivalence methods that differ from recommendations in a relevant product-specific guidance.” The full guidance, entitled Good ANDA Submission Practices, can be found here.

The document identifies specific problems and deficiencies that have been found in ANDAs and provides ways in which to avoid these deficiencies.  The ultimate goal is to help reduce the number of review cycles that cause delays in ANDA approval.  The Agency realizes that they cannot identify and provide discussion of all deficiencies in a single document and has provided the most common recurrent problems seen in ANDA review. The guidance covers the following general issues with each section providing greater granular detail.

  • Patent and Exclusivity Deficiencies
  • Labeling Deficiencies
  • Product Quality Deficiencies
  • Bioequivalence Deficiencies


Maybe I forgot some of the issues raised in the 2018 version of the guidance but reading through the final document reminded me that there is a lot to remember in the regulatory arena and in reading the document carefully, it has informed me of several answers to certain forgotten questions! Enjoy!