Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice." FDA is publishing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act to issue guidance about the use of RWE in regulatory decision-making. This draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that can integrate research into routine clinical practice.
Abstract as published in the Federal Register.
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