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GUIDANCE DOCUMENT

General Considerations for the Clinical Evaluation of Drugs January 1997

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

The objective of clinical investigations is to assess whether a drug is of value in the treatment of prophylaxis of a disease or condition, its risks or undesirable effects, the relative relationship of the assessments.

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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