Submitted Comments

Comments to FDA supporting real-world evidence

The Alliance submitted comments to the FDA supporting its recently issued draft guidance "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” Comments urged the Agency to utilize RWE as a “top programmatic priority” in the regulatory process and supported use of data from registries, claims, and electronic health records in the evaluation of drugs and biologics.