Emily Sachs

Latham & Watkins LLP

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FDA Releases Final Guidance on Considerations for the Use of Real-World Data and Real-World Evidence

The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties. On August 31, 2023, the US Food and Drug Administration (FDA or...more

11/3/2023  /  Federal Food Drug and Cosmetic Act (FFDCA) , Final Guidance , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs
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