BioPharma – USA/Europe/Asia Regulatory Updates, July 2024
USA The FDA approved Femlyv (norethindrone acetate and ethinyl est...
US FDA Requirements for Design Verification and Design Validation Activities
What is Design Verification?
Design Verification is a critical ste...
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...
EU Portable Electronic Devices Change Requirements
Portable Electronic Devices (PED) include digital cameras, smartph...
