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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0528
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.

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All written comments should be identified with this document's docket number: FDA-2009-D-0528.

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