Antidepressant Drugs--Clinical Evaluation

us-fda-guidance-2942d6b42d87f5d5ebe811402545a3aaAntidepressant Drugs--Clinical EvaluationGuidance

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

"General Considerations for the Clinical Evaluation of Drugs" is an important companion piece and should be reviewed prior to reading these guidelines.


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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