FDA Drafts Guidance on Controlled Correspondence Under GDUFA II

The US Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s new commitments related to controlled correspondence under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II).

When finalized, the 20-page guidance will replace guidance from September 2015 from GDUFA I. The GDUFA II commitment letter defines complex controlled correspondence as correspondence related to:

• Evaluation of clinical content
• Review of bioequivalence (BE) protocols for drugs that reference listed drugs with risk evaluation and mitigation strategies (REMS) with elements to assure safe use (ETASU)
• Requested evaluations of alternative BE approaches within the same study type (e.g., pharmacokinetic, in vitro, clinical)

Under the new performance goals, FDA agreed to review and respond to 90% of standard controlled correspondence within 60 calendar days of the date of submission (which compares with responding to 70% within four months of submission from the last GDUFA).

FDA will also review and respond to 90% of complex controlled correspondence within 120 calendar days of the date of submission, and will review and respond to 90% of submitter requests to clarify ambiguities in the controlled correspondence response within 14 calendar days of FDA’s receipt of the request.

"In the case of controlled correspondence that raises an issue that relates to one or more pending citizen petitions, the 60- or 120-calendar day time period starts on the date FDA responds to the petition (if there is only one petition) or last pending petition," the draft says.

This guidance provides additional detail and recommendations on:

• Inquiries FDA considers to be controlled correspondence for the purposes of meeting GDUFA II commitments
• What information requestors should include in a controlled correspondence to facilitate FDA’s consideration of and response to a controlled correspondence
• What information FDA will provide in its communications to requestors submitting controlled correspondence
• How requestors can submit requests to clarify ambiguities in FDA’s controlled correspondence response and the agency’s process for responding to those requests

Controlled Correspondence Related to Generic Drug Development Guidance for Industry: Draft Guidance