FDA Issues Final Guidance on Formal Requests by Generics Makers

The FDA has issued final guidance for generics makers on making formal requests for information, including on topics that are still under agency consideration.

When a drugmaker requests information on a scientific or regulatory issue that the FDA hasn’t yet decided, the request will remain active until the agency makes a determination, the guidance says. The agency will notify the company that the response goal date has been missed because the issues raised are still being assessed, the FDA says.   

The FDA defines “controlled correspondence” as “correspondence submitted to the agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug development.”

In the draft guidance, the FDA proposed notifying the requestor that the policy was under development and the correspondence was closed. The change comes after Apotex requested the agency communicate with drugmakers before closing a correspondence to avoid repeated requests and delays in generic drug development.

The FDA also proposed treating all requests for clarification as new correspondence, since agency staff would use resources to review and respond to follow-up questions.

Apotex and GPhA argued that this might encourage the issuance of partial responses to close out the original correspondence, forcing applicants to weather an additional four-month review cycle for simple clarifications.

In its final guidance, the FDA clarifies that follow-up requests will be treated as new controlled correspondence to ensure that follow-up questions are tracked and that all requestors are treated equitably.

Read Controlled Correspondence Related to Generic Drug Development here: www.fdanews.com/9-15-ANDA-correspondence.pdf. — Jonathon Shacat