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: T...
BioPharma – USA/Europe/Asia Regulatory Updates, Nov 2023
USA | EUROPE | ASIA
USA FDA Publishes Two Final Guidances on Techn...
BioPharma – USA/Europe/Asia Regulatory Updates, Oct 2023
USA | EUROPE | ASIA
USA (FDA) FDA Draft Guidance Pushes for Develo...
BioPharma – USA/Europe/Asia Regulatory Updates, Sept 2023
USA | EUROPE | ASIA
USA (FDA) Guidances Released on EPCIS Standard...
BioPharma – USA/Europe/Asia Regulatory Updates, Aug 2023
USA | EUROPE | ASIA
USA FY 2024 Biosimilar User Fees Show Sharp De...
