April 20, 2026
FDA Reminds Sponsors and Researchers to Disclose Clinical Trial Results to ClinicalTrials.gov
February 16, 2026
FDA Issues Refuse-to-File Letter for mRNA-based Vaccine BLA
December 19, 2025
FDA Issues New Guidance for Enhancing Participation in Drug Clinical Trials
November 20, 2025
FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics
November 19, 2025
FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics
July 8, 2024
Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA
February 20, 2024
FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials
January 10, 2024
FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time
January 3, 2024
FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations
August 24, 2023
FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials
June 30, 2023
FDA Finalizes Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion
March 23, 2020
U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic