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Bev H. Lorell, M.D. (Beverly)
Insights 12 results
Client Alert
December 19, 2025
FDA Issues New Guidance for Enhancing Participation in Drug Clinical Trials
Article · Source: Thomson Reuters Westlaw Today
November 20, 2025
FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics
Client Alert
November 19, 2025
FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics
Client Alert
July 8, 2024
Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA
Client Alert
February 20, 2024
FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials
Client Alert
January 10, 2024
FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time
Client Alert
January 3, 2024
FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations
Client Alert
August 24, 2023
FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials
Client Alert
June 30, 2023
FDA Finalizes Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion
Client Alert
March 7, 2023
FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug
Client Alert
March 23, 2020
U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic
Article
October 31, 2014
Recall Or Enhancement? Read These Medical Device Rules