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Jeffrey K. Shapiro
Insights 24 results
Client Alert
January 9, 2026
FDA Updates General Wellness and Clinical Decision Support Guidance Documents
Article · Source: Law360
June 12, 2025
5 Open Questions About FDA's AI-Assisted Review Plans
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
Client Alert
May 9, 2025
New Executive Order Promotes Domestic Production of Critical Medicines
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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions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
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Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance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FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs
Client Alert
July 5, 2024
The LDT Final Rule Goes Into Effect Today
Client Alert
April 30, 2024
LDT Final Rule: Shifting the LDT Battlefield