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GUIDANCE DOCUMENT

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

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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

Issued by:
Guidance Issuing Office
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This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs.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

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.