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Pharmaceutical and Medical Device
Insights 57 results
Client Alert
January 13, 2025
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)
Client Alert
January 6, 2025
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
Client Alert
December 13, 2024
FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions
Client Alert
September 4, 2024
Transitional Coverage for Emerging Technologies: CMS’s Latest, But Not Necessarily Greatest, Coverage with Evidence Approach
Client Alert
August 23, 2024
Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance
Client Alert
August 8, 2024
DOJ Announces Corporate Whistleblower Awards Pilot Program
Client Alert
July 22, 2024
EU Artificial Intelligence Regulation Published - What You Need to Know
Article · Source: Bloomberg Law
July 15, 2024
Medical Device Makers Must Review Approach After California Case
Client Alert
July 12, 2024
FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs
Client Alert
July 8, 2024
Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA
Client Alert
Article · Source: Medtech Insight Citeline Commercial
June 6, 2024
The Sky Is Not Falling – There's Time To Prep for Quality Management System Regulation's Launch