Brenna Moreno

Brenna Moreno

King & Spalding

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FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more

3/8/2023  /  21st Century Cures Act , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Draft Guidance , Electronic Medical Records , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs
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