General Considerations for the Clinical Evaluation of Drugs January 1997
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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.