title: International Conference on Harmonisation; Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers; availability. Notice.
abstract: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E7 Studies in Support of Special Populations: Geriatrics; Questions and Answers.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The questions and answers (Q&A) guidance addresses special considerations for the design and conduct of clinical trials of drugs likely to have significant use in the elderly. The Q&As are intended to provide guidance on the use of geriatric data to adequately characterize and represent the safety and efficacy of a drug for a marketing application, including data collected postmarketing.
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002626:Chemistry, Pharmaceutical / Q000592:standards; D003226:Congresses as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D005853:Geriatrics / Q000331:legislation & jurisprudence / Q000592:standards*; D006801:Humans; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D007564:Japan; D012449:Safety / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration