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Jessica Ringel
Insights 22 results
Client Alert
March 10, 2026
FDA Issues Draft Guidance on Responding to FDA Form 483 Observations Following Drug Inspections
Client Alert
February 3, 2026
The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique
Client Alert
January 21, 2026
2025 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement
Client Alert
January 9, 2026
FDA Updates General Wellness and Clinical Decision Support Guidance Documents
Client Alert
June 4, 2025
FDA Issues Two Guidances For the Device Q-Sub Process
Client Alert
May 19, 2025
FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review
Article · Source: Journal of Health Care Compliance
May 1, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
Client Alert
April 4, 2025
FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?
Client Alert
January 10, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
Client Alert
December 13, 2024
FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions
Client Alert
August 23, 2024
Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance
Client Alert
July 12, 2024
FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs