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
Compliance Trainings
5939 Candlebrook Ct,, 5, Mississauga, L5V 2V5, Canada
4169154458
Contact us by email
5939 Candlebrook Ct,, 5, Mississauga, L5V 2V5, Canada
4169154458
Contact us by email
Related events
New Zealand Institute of Chemistry Conference 2024 (NZIC-24)
24 November 2024 14:00 - 28 November 2024 14:00, Dunedin, New Zealand
Drugging the Multimorbidity Associated with Ageing
17 January 2025 09:30-17:00, London, United Kingdom
Future Labs Live Basel
27 May 2025 09:00 - 28 May 2025 17:00, Basel, Switzerland
European Glycoscience Community Webinar Series
25 January 2024 15:00 - 19 December 2024 18:00
Search
Advertisement
Spotlight
Explore
Membership
