U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. E8 General Considerations for Clinical Trials
  1. Regulatory Information

GUIDANCE DOCUMENT

E8 General Considerations for Clinical Trials December 1997

Final

E8 General Considerations for Clinical Trials

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

The Food and Drug
Administration (FDA) is publishing a
guidance entitled ‘‘E8 General
Considerations for Clinical Trials.’’ The
guidance was prepared under the
auspices of the International Conference
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance sets forth general
scientific principles for the conduct,
performance, and control of clinical
trials.
 


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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.