FDA final guidance for industry on use of real-world data and real-world evidence to support regulatory decision-making

The guidance, entitled, ‘Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products’, reflects the agency’s current thinking about the use of real-world evidence in regulatory decision-making.  The FDA has announced publication of final guidance on the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making for drugs and biological products. The guidance, entitled, ‘Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products’, provides clarity on the FDA's expectations for clinical studies using RWD. The draft version of...