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ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry October 2017


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs.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 we have 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).

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-5846.