Wayne H. Matelski’s Insights

51 total results. Page 1 of 5.

Health Care Counsel Blog
FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court
Alerts
Mass Layoffs Begin At the FDA
Alerts
FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews
Events
Regulatory Issues for Life Sciences Companies in 2025
AI Law Blog
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
Alerts
FDA Study Finds Biosimilars Are Interchangeable
Health Care Counsel Blog
Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies
Alerts
FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests
Alerts
FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications
Alerts
FDA Issues New Enforcement Policy for Face Masks and Barrier Face Coverings
Press Release
ArentFox Schiff Uses Lanham Act to Secure $3.9 Million False Advertising Victory for Azurity Pharmaceuticals
Press Release
ArentFox Schiff Advised NorthView Acquisition Corp. in its $264M Merger with Profusa, Inc.