How the Industry Can Help With New FDA Guidance on Generic Drug Development

In order to facilitate timely access to high quality, affordable generic medicines, the FDA has implemented two drug program enhancements with the goal of improving communication during the review cycle of an original abbreviated new drug application (ADNA): Discipline Review Letters (DRL) and Information Requests (IR).   The FDA explains in their recently published draft guidance, entitled Information Requests and Discipline Review Letters Under Generic Drug User Fee Amendments (GDUFA), how they intend to deploy these programs.   

This draft is being distributed for comment purposes only.  Once you have read the draft completely, the FDA would like to hear your feedback and consider your comments before it begins to work on the final version of the guidance. You can submit your comments online by clicking here, by February 16, 2018.

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The anticipated impact of IRs and DRLs is to improve the FDA’s predictability and transparency, promote the efficiency and effectiveness of the review process, minimize the number of review cycles necessary for approval and increase FDA’s overall rate of approval, and facilitate greater access to generic drug products.

The Guidance States that the FDA Will Issue:

  • An IR to request further information or clarification that is needed or would be helpful to allow completion of a discipline review.
  • A new type of letter for ANDAs, known as a DRL, to convey preliminary thoughts on possible deficiencies found by a discipline reviewer and/or review team for its or their portion of the application under review after a discipline review.


Here’s How the Industry Can Help:

  1. Submit high quality ANDAs from the start:
  • As the saying goes, the long way is the short way.  Be sure to submit a high quality package right from the start.
  1. Respond to the IR and DRL promptly
  • Your delay in responding will lengthen the approval process because they will not move forward with your application until they hear back from your team.
  1. Submit only requested information:
  • Although tempting to purge all of your data to FDA, it is important to respond only to specific requests and be as clear as possible.
  1. Learn from previous DRL and IRs:
  • Working with the FDA is a skill. The more you can learn from your experiences the better and more efficient your team will be to get drugs approved faster.

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