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In this section: Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Withdrawn CDER Product Specific Guidances March 2019

Final

Docket Number:: FDA-2013-D-1543
Issued by:: Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

Updated March 18, 2021

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-2013-D-1543.

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