Policy Document • Comments

In February 2023, FDA issued draft guidance entitled “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.” This draft guidance provides recommendations for using externally controlled trials to demonstrate the safety and effectiveness of drugs.

Policy Document • Comments

In December 2021, FDA issued draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance outlines various regulatory considerations for submissions containing RWD/E.

Policy Document • Comments

In November 2021, FDA issued draft guidance entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry.” This draft guidance provides recommendations for using RWD derived from data registries to support regulatory submissions.

Policy Document • Comments

In October 2021, FDA issued draft guidance entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” This draft guidance provides recommendations for applying FDA’s currently supported data standards to submissions containing RWD.