ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions - New FDA Guidance Document

The FDA has issued draft guidance for industry entitled ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions. As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), stakeholders agreed to pre-submission facility correspondence (PFC) as a mechanism to obtain a shorter GDUFA goal date for priority Abbreviated New Drug Applications (ANDAs), their amendments, and Prior Approval Supplements (PASs). Submission of the PFC 2 to 3 months prior to the ANDA, PAS, or amendment, will facilitate the FDA’s assessment of the facilities in the application, including whether an inspection is necessary.   The draft guidance document outlines the information that should be submitted in a PFC to support the FDA’s facility assessment.

In order to qualify for the shorter review goal date, the information submitted in the PFC must be complete and accurate;  there must be no changes with respect to facility information when the applicant submits the associated ANDA, PAS, or amendment; and the application when submitted must meet the FDA’s criteria for expedited review under the Center for Drug Evaluation and Research’s Manual of Policy and Procedure 5240.3,Prioritization of the Review of Original ANDAs, Amendments, and Supplements.   As defined in the Commitment Letter, a change with respect to facility information is a change to information in the PFC that causes the FDA to re-evaluate its facility assessment.

The FDA has established a public docket for comments on the draft guidance. The public may submit comments at any time; however, in order to ensure that the FDA considers them before finalizing the draft guidance, comments should be submitted within 60 days of publication of the Federal Register notice: June 20th, 2017.