federal_register: 2021-26737

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2021-26737 Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Anti-Infective Drug Products for the Pediatric Population." The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses enrollment strategies, extrapolation of efficacy, safety database, and other considerations to help facilitate pediatric anti-infective drug product development. This guidance finalizes the draft guidance of the same title issued on June 30, 2020. 2021-12-10 2021 12 https://www.federalregister.gov/documents/2021/12/10/2021-26737/development-of-anti-infective-drug-products-for-the-pediatric-population-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2021-12-10/pdf/2021-26737.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Anti-Infective Drug Products for the Pediatric Population." The purpose of this guidance is to provide general...

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