Tag: USA Regulations

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Feb 2025

March 11, 2025
Medical Device

USA Guidance on Institutional Review Board (IRB) Written Procedures The FDA and HHS OHRP have jointly issued the final guidance on Institutional Review Board (IRB) Written Procedures to enhance...

Asia Regulations, Europe Regulations, Global Regulatory, Healthcare Regulations, Med Tech Updates, Medical Device News, Medical Devices, Regulatory Updates, ROW Regulatory, USA Regulations

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Feb 2025

March 11, 2025
Biopharma

USA FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes The U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog...

Asia Biotech, Biotech 2025, Biotech Insights, Biotech Updates, Europe Pharma, Pharma News, Pharma Regulations, Pharma Trends, Regulatory Affairs, ROW Regulatory, USA Regulations

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Aug 2024

September 4, 2024
Medical Device

USA Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers The VMSR (Voluntary Malfunction Summary Reporting) Program allows device manufacturers to report certain device...

Asia Regulations, Europe Regulations, Global Compliance, Global Regulatory Updates, Healthcare Regulations, Medical Device Regulations, Medical Devices, Regulatory Updates, USA Regulations