Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability

Documents

Comments

Key Dates

Comment Period OpensSep 30, 2021

Comment Period ClosesJan 25, 2022

Type	Title	Posted	Comments	Status
Other	Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry	Jul 25, 2024	2

Total Comments

CDER

2020-670

Real-World Data: Assessing

Electronic Health Records and Medical Claims

Data to Support Regulatory Decision-Making

for Drug and Biological Products

Draft Guidance for Industry

Availability