A few days ago, the FDA published a guidance document titled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions (see here) that describes three checklist attachments for various types of ANDAs and related submissions.  The checklists are identified as being voluntary, but the OGD suggests that not only can they aid applicants in ensuring that the contents of their submission are complete, but their inclusion in submissions will assist the OGD in its initial triage and help ensure assignment to the appropriate assessors.

The three types of checklists are found in the appendices to the guidance:

  • Appendix 1: Cover Letter Attachment for Controlled Correspondence
  • Appendix 2: Cover Letter Attachment for Original ANDAs, Amendments to Original ANDAs, and General 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 General Correpondence Related to These Submissions

The Agency says that failure to include a checklist in the submission will not be considered a deficiency or a basis for a refuse‑to‑receive action, but the OGD hopes that firms will include the document along with the cover letter.  The Agency also reminds firms that the checklist does not take the place of the cover letter, which is used to outline what is in the submission and to outline any unusual circumstances or issues that the applicant believes necessary for explanation purposes.  The guidance also states that firms can find the “[R]ecommended content of cover letters (or first page of submission) provided in the following guidances for industry: Controlled Correspondence Related to Generic Drug Development (December 2020); ANDA Submissions—Content and Format (June 2019); ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA (July 2018); and ANDA Submissions—Prior Approval Supplements Under GDUFA (October 2017).”

Along with all of the other checklists, guidances, MaPPs, and other information available on ANDA submissions, this guidance may add another layer of workload for firms, but it might just be worth it so you don’t inadvertently leave an important piece of information out of the submission.  Like a favorite saying of carpenters, “measure twice, cut once!”  A good idea would be to measure your submission against the checklists twice before filing it—maybe you will avoid receiving an RTR letter instead of an acknowledgement letter or a Complete Response Letter (CRL) instead of an approval.