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Jeffrey K. Shapiro
Insights 20 results
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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions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Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance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FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs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
Client Alert
March 25, 2024
FDA Publishes White Paper on Artificial Intelligence & Medical Products
Client Alert
January 10, 2024
FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time
Client Alert
January 3, 2024
FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations
Article · Source: Law360
November 6, 2023
FDA's Off-Label Comms Guidance Is A Reluctant Step Forward