federal_register: E9-27000

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-27000 International Conference on Harmonisation; Draft Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E7 Studies in Support of Special Populations: Geriatrics; Questions & Answers." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft questions and answers (Q&A) guidance addresses the representation of geriatric patients in the clinical database, including representation of special characteristics of the geriatric patient population. The Q&As are intended to provide guidance on this issue. 2009-11-10 2009 11 https://www.federalregister.gov/documents/2009/11/10/E9-27000/international-conference-on-harmonisation-draft-guidance-on-e7-studies-in-support-of-special https://www.govinfo.gov/content/pkg/FR-2009-11-10/pdf/E9-27000.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E7 Studies in Support of Special Populations: Geriatrics; Questions & Answers." The draft guidance was prepared under the auspices of the International...

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