IND Submission 2012 - IND Submission for a 505(b)(2) Product

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. However, 505(b)(2) products require evidence from clinical trials conducted under an IND in support of the marketing approval application.
Pricing
Live Session for one participant
Price: $243.00
Corporate Live Session 4 to 10 participants in single location.
Price:$986.00
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $288.00