On December 10, 2021, the FDA issued a guidance titled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions, which can be found here.  The guidance suggests that ANDA applicants can help their own causes by utilizing a checklist as an attachment to the cover letters of ANDA submissions and controlled correspondences submitted to the Agency.  The attachment would provide a summary of the submission in a standard format, which will help ensure that the submission gets to the correct disciplines within the proper functional review unit within the Office of Generic Drugs or the Office of Product Quality.

The guidance provides example of checklists in three separate appendices:

  • APPENDIX 1: COVER LETTER ATTACHMENT FOR CONTROLLED CORRESPONDENCES
  • APPENDIX 2: COVER LETTER ATTACHMENT FOR ORIGINAL ANDAS, AMENDMENTS TO ORIGINAL ANDAS, AND CORRESPONDENCE RELATED TO ORIGINAL APPLICATIONS
  • APPENDIX 3: COVER LETTER ATTACHMENT FOR SUPPLEMENTS TO APPROVED ANDAS, AMENDMENTS TO PENDING SUPPLEMENTS, AMENDMENTS TO TENTATIVELY APPROVED PEPFAR ANDAS, AND CORRESPONDENCE RELATED TO THESE SUBMISSIONS

The Agency notes that this provides ANDA applicants with the chance to include “optional attachments that can be used when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.  These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidances” (emphasis added) but may provide a standard format for information that permits Agency staff to better recognize the nature of submissions to ensure that they move through the review process more quickly.  We all know that the cover letter is a key document in the submission, but it can get a bit long and complex.  Use of the optional summary tables will ensure that the initial screening will be facilitated.

The guidance states:

“The cover letter provides an overview of the submission and helps FDA ensure that the submission is properly triaged and assigned to the appropriate assessors.  In an effort to ensure that submissions are effectively managed by FDA and acted upon within the performance review goal dates set by the Generic Drug User Fee Amendments (GDUFA), FDA has developed cover letter attachments to accompany, not replace, the applicant’s cover letter for the following common submissions: controlled correspondence, original ANDAs and amendments to ANDAs, and supplements to approved ANDAs” (emphasis added).

While this will increase the work in putting together a submission, it may be of significant help to the FDA and the applicant, and will help ensure that the applicant or the FDA does not miss a critical piece of information that could potentially delay review.