Medical Devices – USA/Europe Regulatory Updates Roundup, July 2024
USA
Medical Device User Fee Rates for Fiscal Year 2025
The Food an...
BioPharma – USA/Europe/Asia Regulatory Updates, July 2024
USA The FDA approved Femlyv (norethindrone acetate and ethinyl est...
US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septemb...
BioPharma – USA/Europe/Asia Regulatory Updates, June 2024
USA
FDA Permits Marketing of First Point-of-Care Hepatitis C RNA T...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Guidance on Laboratory Developed Tests: Small Entity Complianc...
Clinical Data Usage for Medical Device Submissions in EU and US
Clinical Data for Medical Device Submissions in EU
Clinical data f...
