Today, the U.S. Food and Drug Administration (FDA) published the draft guidance for industry entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The draft guidance provides recommendations to industry on post-complete response letter (CRL) meetings between the FDA and abbreviated new drug application (ANDA) applicants to clarify deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act.
It is important that there are efficient, consistent procedures for timely and effective post-CRL meetings. The FDA is issuing this draft guidance to assist applicants in generating and submitting a request for a post-CRL meeting to the agency as described in the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II). This draft guidance provides procedures to promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the timeframes, or performance goals, set forth in the Generic Drug User Fee Amendments Reauthorization (GDUFA II) performance goals and program enhancements Fiscal Years 2018-2022 (GDUFA II goals or commitment letter).
When final, this guidance will represent the agency’s current thinking on this topic. To comment on the draft guidance, please visit the public docket, FDA-2017-D-5928.
Additionally, the FDA has recorded a