Today, start-up and small pharmaceutical companies use the FDA's 505(b)(2) approval pathway to modify and reposition existing drugs for more predictable, lower risk, and less costly marketing clearance. Similar to a 505(b)(1) submission for new molecular entities, 505(b)(2) requires the submission of a full NDA. This 90-minute webinar will teach you why and how a properly submitted 505(b)(2) can be the difference between success and failure of a new drug approval.
Essential First Steps to FDA 505(b) (2) Drug Approval
19 February 2008, United States
Introduction
Venue
Online
Online, United States
Useful links
Organised by
Drug Information Association
Contact information
Mr Marketing Manager
800 Enterprise Road, Suite 200, Horsham, 19044, United States of America
+1.215.442.6100
Contact us by email
800 Enterprise Road, Suite 200, Horsham, 19044, United States of America
+1.215.442.6100
Contact us by email
Search
Advertisement
Spotlight
Explore
Membership
