ANDAs are complicated submissions that involve a lot of data, explanations, and clear and concise statements.  There is often also an associated rush to meet a deadline for ANDA submission that has the potential to create errors, either by omitting important data or not providing sufficient clarity in the submission.  At the AAM GRx+Biosims meeting held in Bethesda, Maryland last week, Karen Ireland, M.S., Supervisory Regulatory Health Project Manager, provided some good tips and insight into how to help ensure that your application avoids delays in approval.  Below are a few of her helpful tips:

  • There are a number of opportunities for prioritization of ANDAs; if your submission falls within one of the relevant categories, be sure that you clearly request prioritization. See MaPP 5240.3 Prioritization of the Review of Original ANDAs, Amendments, and Supplements (here) for more information.  Failure to make such a request could cost you valuable time in the review process unnecessarily.
  • For applications with a tentative approval that are waiting for a patent or exclusivity provision resolution, be sure that you are aware of the first full legally approvable date and submit the request for final approval accordingly. Also, don’t forget that submission of major changes in an application with a tentative approval will likely revise the goal date of the application and could delay final approval.
  • Provide complete responses to ANDA deficiencies. Remember, a promise to submit information at a future date may be considered a partial response and may result in the FDA not reviewing any information submitted with that amendment.
  • If a deficiency is unclear, reach out to the discipline project manager for clarification, or you can request a Post-CRL Clarification Teleconference if necessary. Whatever you do, don’t guess!  If your response to the deficiency is not clear, providing a good answer to the wrong question will likely not satisfy the reviewer either.
  • If additional time is needed to respond to a deficiency, request an extension of the response due date but be aware that not all extension requests are granted.
  • Remember that changes to DMFs cited in an application can impact the referencing ANDA’s goal date. To avoid a problem, remain in close contact with the DMF holder and be aware of if and when changes are being made.  Also, if there are facilities cited in the DMF that you will not be referencing, be certain that the letter of authorization clearly notes which DMF facilities are applicable to the ANDA.
  • For patent and exclusivity issues, be certain to address each listed in the Orange Book. Also, remember to include any documentation of litigation outcomes and/or submissions of all court decisions (late submission can impact the timing of approval).
  • If your ANDA is based on an approved ANDA suitability petition, cite the petition number and include a copy of the FDA’s petition approval letter in your submission.

These are all good tips to remember as failure to do so could result in a delay in the review of submitted material or a delay in the approval of an ANDA or a supplemental application.