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Bev H. Lorell, M.D. (Beverly)
Insights 22 results
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 FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA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FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials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FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials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FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug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
November 14, 2022
FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards
Article · Source: WCG CenterWatch
November 1, 2022
Clinical Data Integrity: FDA and DOJ Enforcement Priorities
Client Alert
February 8, 2022
Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials
Client Alert
November 9, 2021
A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making
Client Alert
March 23, 2020
U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic