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Navigating Controlled Correspondence: FDA's Guidance on Generic Drug Development


The FDA has finalized the guidance for industry ““Controlled Correspondence Related to Generic Drug Development” recently. This guidance replaces the December 2020 draft guidance, “Controlled Correspondence Related to Generic Drug Development.” Controlled correspondence, as most of you are aware, are formal written inquiries from developers/applicants seeking clarification on various regulatory matters. Controlled correspondences have been an important tool for Developers and applicants for many years now. 

The guidance outlines the scope and purpose of controlled correspondence, delineating the types of inquiries eligible for submission, defines type of controlled correspondences (Level 1 and Level 2), content and additional recommendations specific inquiries such as, Inactive ingredients, formulation assessment (Q1/Q2) and Product quality, to name a few. An important point to note, FDA’s commitment to review of controlled correspondence received on or after October 1, 2022. (as a part of GDUFA III),  Specifically 60 and 90 days for Level 1 and Level 2 correspondence.

While finalizing the guidance, FDA considered comments received on the draft guidance. Changes from the draft to the final guidance include:

  • Clarification of the role of a cover letter to a controlled correspondence

  • Clarification that authorized agents submitting controlled correspondence should include the name of and contact information for the generic drug manufacturer or related industry they are representing

  • Explanation of FDA’s intent to alert requestors whether their inquiry is a level 1 or level 2 controlled correspondence and if FDA has changed the level of the controlled correspondence (e.g., from level 1 to level 2) during substantive review

In past, Controlled Correspondence had always been a sore spot for Industry, as it used to take not only very long, but also, had a lot of uncertainty. This finalized guidance is a great step towards streamlining the communication between Industry and the agency, helping in Generic product development. Though there still exists a lot of complexity, specially in Product Specific Guidance (PSG) development, and Review of BE/Clinical Protocol for RLD subject to REMS with ETASU.

If your company or organization wishes to submit any correspondences, or has any technical/regulatory related queries for Correspondence, Our Regulatory practice group at PharmaVector can help you do this. Please reach out to us at info@pharmavector.com, or visit our site at www.pharmavector.com 


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