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
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Online, 5939 Candlebrook Ct,, Ontario, Mississauga, L5V 2V5, Canada
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