A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products.
Webinar On - Improved Generic Drugs via the 505(b)(2) Regulatory Pathway: FDA Approval Made Easy
19 February 2014, Mississauga, Canada
Introduction
Venue
Online
Online, 5939 Candlebrook Ct,, Ontario, Mississauga, L5V 2V5, Canada
Useful links
Contact information
Related events
Future Labs Live
26 June 2024 08:00 - 27 June 2024 17:00, Basel, Switzerland
European Glycoscience Community Webinar Series
25 January 2024 15:00 - 19 December 2024 18:00
Chemical Biology Ireland Conference 2024
22 July 2024 10:00 - 23 July 2024 18:00, Galway, Ireland
6th International Conference on Nanomaterials Science and Mechanical Engineering
9 - 12 July 2024, Aveiro, Portugal
Search
Advertisement
Spotlight
Explore
