Posted by Michael Wonder on 09 Dec 2021
FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological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 and clarifies the agency's expectations for sponsors submitting new drug applications or biologics license applications using real world data to support the safety or effectiveness of a drug in clinical studies that are not subject to 21 CFR part 312.
