New FDA Guidance on Controlled Correspondence for Generics

The FDA has updated its draft guidance for generic drugmakers on submitting controlled correspondence to the agency to include new review goals under the reauthorization of the Generic Drug User Fee Amendments (GDUFA III).

The 26-page draft updates a December 2020 draft guidance by revising the number of days the FDA has to respond to level 1 — general requests for information — and level 2 — inquiries about the content and approach to a specific abbreviated new drug application (ANDA).

The FDA agreed to respond to 90 percent of level 1 controlled correspondence within 60 calendar days of the date of submission. The agency also pledged to review and respond to 90 percent of level 2 controlled correspondence within 120 calendar days of the date of submission.

Also, the FDA will review and respond to 90 percent of submitter requests to clarify ambiguities in the controlled correspondence response within 21 calendar days of receipt of the request.