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GUIDANCE DOCUMENT

Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications February 1987

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guideline is intended to assist drug firms in preparing the summary to a new drug application required under 21 CFR 314.50(c).

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.

 
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