Division of Clinical Research

Office of the Vice President and Innovation

On December 16, 2020, FDA announced the availability of the final guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.”

This final guidance provides information on the following:

  • Process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development
  • Agency communications related to controlled correspondence
  • Process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA’s controlled correspondence response

Revisions to the draft guidance include:

  • Clarification on FDA’s practices regarding controlled correspondence that is related to a pending petition
  • What information should be submitted with a request related to an inactive ingredient
  • When FDA may determine an inquiry is a complex controlled correspondence
  • The recommendation that requestors submit their controlled correspondence through the CDER Direct NextGen Collaboration Portal (more information on using the portal is available online)

While finalizing this guidance, the Agency considered comments on the draft guidance announced in the Federal Register on November 3, 2017 (82 FR 51277). 

The final guidance can be viewed online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/controlled-correspondence-related-generic-drug-development-draft-guidance-industry 

Categories Policies & Guidance
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