Beverly Lorell, MD

King & Spalding

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Latest Posts › 21st Century Cures Act

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FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more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Cures Act , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Draft Guidance , Electronic Medical Records , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards

The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more

11/15/2022 / 21st Century Cures Act , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , HIPAA Privacy Rule , Informed Consent , Institutional Review Board (IRB) , New Regulations , Personally Identifiable Information , Proposed Rules , Waivers

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

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

2/2/2017 / 21st Century Cures Act , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Informed Consent , Life Sciences , Research and Development , The Common Rule

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