FDA Issues Draft Guidance on "External Controls" in Clinical Trials to Support Safety and Efficacy of a Drug | King & Spalding
The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the...
World Evidence Program Drug Administration Externally Controlled Trials Biological Products Controls Draft Century Cures Act
Source: jdsupra.com