USA – FDA issues final guidance on controlled correspondence

The US Food and Drug Administration (FDA) has finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence process.

The final guidance document, issued on 16 December, updates a draft that the agency released in 2017 (RELATED: FDA Drafts Guidance on Controlled Correspondence Under GDUFA II,” Regulatory Focus 02 November 2017).

The guidance incorporates changes that were part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA II). Revisions include clarification about how the agency handles controlled correspondence related to a pending petition, what information should be submitted for requests related to an inactive ingredient, and when the agency may determine that an inquiry is a “complex” controlled correspondence…