Brenna Moreno

Brenna Moreno

King & Spalding

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FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more

8/25/2023  /  Abbreviated New Drug Application (ANDA) , Clinical Trials , Data Collection , Diversity and Inclusion Standards (D&I) , Draft Guidance , Food and Drug Administration (FDA) , License Applications , Pharmaceutical Industry , Prescription Drugs
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