Eva Temkin

King & Spalding

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Latest Posts › New Guidance

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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

FDA Issues New Draft Guidance for Sponsors on Safety Event Analysis and Reporting for IND and Bioavailability/Bioequivalence...

Focuses on Aggregate Safety Data Analysis and Expedited Reports; Expectation for Prospective Safety Surveillance Plan - The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more

7/27/2021 / Clinical Trials , Draft Guidance , Final Rules , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , New Guidance , Sponsors

Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid

There has been much discussion about FDA’s recently-issued guidance regarding the development and review of abbreviated new drug applications (“ANDAs”) during the COVID-19 pandemic. The guidance, “Development of Abbreviated...more

4/23/2021 / Abbreviated New Drug Application (ANDA) , Biosimilars , BPCIA , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Interchangeability , Marketing Exclusivity Periods , New Guidance , Pharmaceutical Patents , Public Health Service Act

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