FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers

On October 3, 2017, FDA issued draft guidance to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs.  This guidance provides answers to questions FDA has received from applicants regarding the guidance for industry, ANDA Submissions—Refuse-to-Receive Standards (RTR Standards guidance) and the filing review process, in general.  The questions and answers address general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to Drug Master Files (DMFs), product quality, and bioequivalence (BE) and clinical reviews, and are intended to clarify the deficiencies that may cause FDA to refuse to receive (RTR) an ANDA.  An RTR decision indicates that FDA has determined that an ANDA is not a substantially complete application (i.e., that the ANDA, on its face, is not sufficiently complete to permit a substantive review).

FDA is accepting comments on this draft guidance through December 4, 2017.

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