Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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 This guidance finalizes the draft guidance of the same title issued on November 30, 2021.
Abstract as published in the Federal Register.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account