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FDA Issues Draft Guidance for Industry on use of Real-World Data

FDA Issues Draft Guidance for Industry on use of Real-World Data
December 17, 2021 SueCarr

The FDA has issued draft guidance for industry on recommendations for the use of real-world data and real-world evidence to support regulatory decision-making for drugs and biological products.

The U.S. Food and Drug Administration issued a draft guidance for industry titled ‘Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological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 using RWD to support the safety or effectiveness of a drug in clinical studies that are not subject to 21 CFR part 312.

Click here to view draft guidance document.