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In this section: Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Withdrawn CDER Product Specific Guidances March 2019

Final

Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

Updated March 7, 2019

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:

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

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