A presentation delivered by Office of Generic Drugs Director, Iilun Murphy, M.D. during the members-only Regulatory and Policy meeting at the start of AAM’s annual meeting provided seven tips for ANDA sponsors with regard to their ANDA submissions:

  1. Submit a clear cover letter.
    1. Describe what is being submitted.
    2. State whether the submission includes a labeling carve-out.
    3. The OGD strongly suggests using the cover letter attachment, especially if (i) submitting a large, complicated submission, (ii) there is unexpected, unsolicited information included, or (iii) certain data or studies needs to be submitted to a particular discipline.
  2. Respond thoroughly to all requests and deficiencies in IRs, DRLs, and CRLs.
  3. Monitor updates in the RLD labeling, the Orange Book, the USP, and guidances.
  4. Submit litigation-related updates in a timely manner.
  5. Remain in good standing by avoiding data integrity issues.
  6. Coordinate DMF changes and avoid failing to report “hidden” facilities.
  7. Pay attention to patents.
    1. Address all patents in the OB.
    2. For new patents, submit PIV certifications on the first day that the patent is published in the OB.

 

These tips represent areas where a lot of time can be lost in the review process or when a firm may miss out on a first-to-file opportunity.