Posted by Michael Wonder on 29 Nov 2021
FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products."
The draft guidance provides sponsors and other stakeholders with considerations when either designing a registry or proposing to use an existing registry to support a regulatory decision about a drug’s effectiveness or safety.
