Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Aug 2024
USA
Voluntary Malfunction Summary Reporting (VMSR) Program for Ma...
BioPharma – USA/UK/Asia Regulatory Updates, Aug 2024
USA
FDA Approves First Nasal Spray for Treatment of Anaphylaxis
T...
Understanding UDI Requirements for Medical Devices: A Comprehensive Guide
The Unique Device Identification (UDI) system is a global initiat...
Medical Devices – USA/Europe Regulatory Updates Roundup, July 2024
USA
Medical Device User Fee Rates for Fiscal Year 2025
The Food a...
BioPharma – USA/Europe/Asia Regulatory Updates, July 2024
USA The FDA approved Femlyv (norethindrone acetate and ethinyl es...
US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septem...