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ANDA Submissions -- Refuse-to-Receive Standards Rev.2 December 2016

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product.2 The guidance highlights deficiencies that may cause FDA to refuse to receive (RTR) an ANDA.3 An RTR decision indicates that FDA determined that an ANDA is not substantially complete.4 A substantially complete ANDA is “an ANDA that on its face is sufficiently complete to permit a substantive review.”5

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-2013-D-1120.

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