March 10, 2026
FDA Issues Draft Guidance on Responding to FDA Form 483 Observations Following Drug Inspections
February 3, 2026
The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique
January 21, 2026
2025 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement
January 9, 2026
FDA Updates General Wellness and Clinical Decision Support Guidance Documents
June 4, 2025
FDA Issues Two Guidances For the Device Q-Sub Process
May 19, 2025
FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review
May 1, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
April 4, 2025
FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?
January 10, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
December 13, 2024
FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions
August 23, 2024
Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance
July 12, 2024
FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs