federal_register: 2023-28289

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2023-28289 Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products." This guidance provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug's effectiveness or safety. FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance on the use of RWE in regulatory decision-making. This guidance finalizes the draft guidance of the same title issued on November 30, 2021. 2023-12-22 2023 12 https://www.federalregister.gov/documents/2023/12/22/2023-28289/real-world-data-assessing-registries-to-support-regulatory-decision-making-for-drug-and-biological https://www.govinfo.gov/content/pkg/FR-2023-12-22/pdf/2023-28289.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 "Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products." This guidance...

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