September 11, 2025
Advancing Novel Treatments for Rare Diseases: FDA Unveils and Previews New Efforts to Assess Therapies for Very Small Patient Populations
July 11, 2025
FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come
May 9, 2025
New Executive Order Promotes Domestic Production of Critical Medicines
January 6, 2025
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
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 FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA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FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials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
December 21, 2023
FDA Ushers in New Program for Drug Products Manufactured Using Innovative Manufacturing Technologies
October 23, 2023
How Int'l Regulatory Collabs Can Expedite Pharma Approvals
August 24, 2023
FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials