us-fda-guidance-5ad17e9af766fcda580390f67abcb1a0•Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications
Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications
us-fda-guidance-5ad17e9af766fcda580390f67abcb1a0Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic ApplicationsGuidance
Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.
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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