Eva Temkin

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FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more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Abbreviated New Drug Application (ANDA) , Clinical Trials , Data Collection , Diversity and Inclusion Standards (D&I) , Draft Guidance , Food and Drug Administration (FDA) , License Applications , Pharmaceutical Industry , Prescription Drugs

A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more

2/8/2022 / Clinical Trials , Coronavirus/COVID-19 , Data Collection , Data Privacy , Digital Health , Food and Drug Administration (FDA) , Investigations , Medical Devices , New Guidance

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

11/10/2021 / 21st Century Cures Act , Data Collection , Drug Approvals , EHR , Food and Drug Administration (FDA) , Medical Devices , New Guidance , Pharmaceutical Industry , Prescription Drugs , Real World Evidence

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