FDA Issues Draft Guidance for Industry, Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products
The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products. The guidance discusses the applicability of FDA's investigational new drug (IND) application regulations under 21 CFR part 312 to clinical study designs that use real-world data (RWD) and clarifies the agency's expectations for sponsors submitting new drug applications or biologics license applications using RWD to support the safety or effectiveness of a drug in clinical studies that are not subject to 21 CFR part 312.
For non-interventional (observational studies), which are not subject to FDA’s IND regulations, the draft guidance outlines the agency’s expectations regarding the design and conduct of such studies including access to relevant datasets, study monitoring, maintaining case records, and early discussions with the relevant review divisions. FDA is issuing this guidance to assist stakeholders in meeting its expectations and to ensure that the agency can appropriately evaluate non-interventional studies that are submitted in marketing applications to support the safety and effectiveness of a drug.
This draft guidance is part of a series of guidances that FDA has already published, or plans to publish, as part of the agency’s RWE Program and in support of the 21st Century Cures Act and the Prescription Drug User Fee Act.
For information on the draft guidance and how to comment, please see the Federal Register Notice.
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