FDA Updates Generics Correspondence Guidance for GDUFA II

The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1.

The draft guidance describes the process for submitting controlled correspondence to the FDA — such as requests for information on specific drug product development, evaluation of clinical content or reviews of bioequivalence protocols —and the agency’s timeline for providing a response. The new document replaces a 2015 draft guidance focused on GDUFA I.

Under the GDUFA II agreement, sponsors should expect the FDA to respond to standard communications within 60 calendar days, with more complex requests taking 120 days. The FDA will not treat pre-ANDA meeting requests as controlled correspondence.