ISPOR Seeks Comments for FDA Guidance on RWD

The International Society for Pharmacoeconomics and Outcomes (ISPOR) is seeking comments for a draft guidance document published by the Food and Drug Administration (FDA) detailing how to select appropriate real world data (RWD) sources. The comment period closes in early November.

“The survey below provides spaces for comments on each section of the US FDA’s draft guidance, issued September 30, 2021, entitled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products”… The survey response deadline is 8:00pm EST (UTC -5) on Wednesday, November 3, 2021.” Access the survey here.

(Source: ISPOR, 10/21)