BioPharma – USA/Europe/Asia Regulatory Updates, July 2024
USA The FDA approved Femlyv (norethindrone acetate and ethinyl es...
BioPharma – USA/Europe/Asia Regulatory Updates, June 2024
USA
FDA Permits Marketing of First Point-of-Care Hepatitis C RNA ...
BioPharma – USA/Europe/Asia Regulatory Updates, April 2024
USA Content and Format of Composition Statement and Corresponding...
IND and NDA applications: US
The two primary application types for the approval of new drugs: ...
BioPharma – USA/Europe/Asia Regulatory Updates, Nov 2023
USA | EUROPE | ASIA
USA FDA Publishes Two Final Guidances on Tech...
BioPharma – USA/Europe/Asia Regulatory Updates, Oct 2023
USA | EUROPE | ASIA
USA (FDA) FDA Draft Guidance Pushes for Devel...