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ICH Draft Guidance on Studies of Geriatric Populations

11/10/2009

Federal Register Notice: FDA is making available a draft guidance entitled E7 Studies in Support of Special Populations: Geriatrics; Questions & Answers prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It addresses the representation of geriatric patients in the clinical database, including representation of special characteristics of the geriatric patient population. To download this guidance, click here. To view this notice, click here.

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