Generic Drug Controlled Correspondence Revised Guidance

FDA has published a draft guidance, Controlled Correspondence Related to Generic Drug Development, with information on the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. The document also describes the agency’s process for providing communications related to such correspondence.

The draft revises a 12/2020 guidance and will replace that guidance when it is finalized. FDA says the new draft is being issued to incorporate program enhancements related to the review of controlled correspondence to which FDA committed and industry agreed for the GDUFA 3 reauthorization. Other significant changes from the 12/2020 version include providing additional recommendations for specific types of inquiries in controlled correspondence, FDA says.