On June 4th, the FDA issued a guidance document titled Certain Postapproval Requirements and Resources for ANDAs (here) in an effort to streamline ANDA approval letters. Previously, each ANDA approval letter had certain information regarding standard or specific post-approval requirements. Instead, the new guidance document provides a listing of the standard requirements and responsibilities of applicants after ANDA approval.

By release of this guidance, we can expect to see shorter ANDA approval letters rather than an exhaustive listing of post-approval requirements in the letters and, in many cases, expect a singular reference to this guidance. Regarding approval letters, the guidance states that ANDA approval “letters have included general and largely standardized information to serve as reminders to ANDA holders of certain postapproval statutory and regulatory obligations. In addition, FDA has provided various publicly available resources, including guidances for industry, which discuss and may provide recommendations on the same ANDA postapproval requirements typically highlighted in the approval letters. In an effort to streamline ANDA approval letters, the Agency has been removing some of the information on postapproval requirements typically included in the letters, while continuing to provide ANDA holders with a helpful resource to reference reminders about certain postapproval requirements.”

It further notes that “[h]olders of approved ANDAs should consider all other relevant CDER guidance documents for additional recommendations related to postapproval requirements.”

The guidance discusses the following requirements that may soon disappear from approval letters and provides advice on the actions that ANDA sponsors are required to take after approval (albeit perhaps no longer explicitly stated in the approval letter):

  • Changes to an approved ANDA
  • Conversion of ANDA approval to tentative approval because of court order
  • Postmarketing reporting requirements
  • Postmarketing safety surveillance
  • Combination product safety reporting
  • Notice of permanent discontinuation or interruption in manufacturing
  • Promotional materials
  • Annual facility fees
  • Content of labeling
  • Risk evaluation and mitigation strategies
  • Competitive generic therapy – notice of first commercial marketing
  • 180-day exclusivity – notice of first commercial marketing
  • Compendial standards

This handy guidance document will be a perfect reference for helping to ensure that firms meet their post-approval reporting requirements. However, it’s important to remember that not all requirements are provided in this guidance. Be hypervigilant to ensure that you meet and continue to meet all post-approval requirements after you receive an ANDA approval letter. This is especially important to make certain that you don’t forfeit any of the potential benefits that could be associated with your approved ANDA.