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Bev H. Lorell, M.D. (Beverly)
Insights 22 results
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FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug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
Client Alert
December 11, 2020
Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud
Client Alert
November 19, 2020
Heightened Focus on Foreign Influence in Academia
Client Alert
August 17, 2020
Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements
COVID-19 Vaccine Updates
June 10, 2020
Advice for Companies Attempting to Limit Liability from Vaccine Trials
Article · Source: Law360
June 10, 2020
COVID-19 Vaccine Developers Can Limit Liability From Trials
Client Alert
March 23, 2020
U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic