Posted by Michael Wonder on 21 Oct 2021
FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data
21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological Product Submissions Containing Real World Data.
The guidance provides recommendations to sponsors for complying with the Federal Food, Drug and Cosmetic Act when submitting study data derived from real world data sources in an applicable regulatory submission using standards specified in the Data Standards Catalog.
