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GUIDANCE DOCUMENT

Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry December 2017

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2017-D-6554
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Guidance for Industry

Submit Comments

Submit Comments Online

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-6554.

 
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