Policy Document • Comments

In December 2021, FDA issued draft guidance titled “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance outlines various regulatory considerations for submissions containing RWD/E. The RWE Alliance commented on the draft guidance in March 2022, and FDA issued final guidance in August 2023.

Policy Document • Comments

In March 2023, FDA issued draft guidance titled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.” This draft guidance provides recommendations to sponsors of oncology products on considerations for designing trials intended to support accelerated approval.

Policy Document • Comments

In February 2023, FDA issued draft guidance titled “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.” This draft guidance provides recommendations for using externally controlled trials to demonstrate the safety and effectiveness of drugs.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In November 2021, FDA issued draft guidance titled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry.” This draft guidance provided recommendations for using RWD derived from data registries to support regulatory submissions.  The RWE Alliance commented on the draft guidance in February 2022, and FDA issued final guidance in December 2023.

Policy Document • Comments

In October 2021, FDA issued draft guidance titled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” This draft guidance provided recommendations for applying FDA’s currently supported data standards to submissions containing RWD. The RWE Alliance commented on the draft guidance in February 2022, and FDA issued final guidance in December 2023.

Policy Document • Comments

In September 2021, FDA issued draft guidance titled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance provides recommendations for using real-world evidence derived from electronic health records and medical claims data for regulatory decisions across therapeutic areas.