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GUIDANCE DOCUMENT

E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1) January 2013

Final

E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1)

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

Since the ICH E3 guidance was made final, experiences implementing the guidance in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to facilitate implementing the ICH E3 guidance by clarifying key issues.
 


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.