Beverly Lorell, MD

Beverly Lorell, MD

King & Spalding

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Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA

On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more

7/9/2024  /  Clinical Trials , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more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New Drug Application (ANDA) , Clinical Trials , Data Collection , Diversity and Inclusion Standards (D&I) , Draft Guidance , Food and Drug Administration (FDA) , License Applications , Pharmaceutical Industry , Prescription Drugs

FDA Finalizes Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion

On June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more

7/3/2023  /  Advertising , Direct to Consumer Sales , Draft Guidance , Final Guidance , Food and Drug Administration (FDA) , Labeling , Prescription Drugs

FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more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Cures Act , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Draft Guidance , Electronic Medical Records , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

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

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

8/20/2020  /  Civil Monetary Penalty , Clinical Trials , Compliance , Corrective Actions , Department of Health and Human Services (HHS) , Federal Register , Food and Drug Administration (FDA) , Medical Devices , National Institute of Health (NIH) , Prescription Drugs
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