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GUIDANCE DOCUMENT

E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers February 2012

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

The ICH guidance E7 Studies in Support of Special Populations: Geriatrics provides recommendations
on special considerations that apply in the design and conduct of clinical trials of medicines that
are likely to have significant use in the elderly. Since the E7 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 clarify 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:

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.