FDA 505(b)(2) Applications Seminar Part I: Where does a 505(b)(2) fit?

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Regis Technologies, Inc.

Regis Technologies hosted a seminar on FDA 505(b)(2) Applications in March 2016. Two guest speakers from PAREXEL Consulting, Aloka Srinivasan, Ph.D., and Partha Roy, Ph.D., delivered excellent information and led an engaging discussion on this convenient New Drug Application (NDA) approval pathway for the pharmaceutical industry. The video is broken into eight parts. Start with this first part for an introduction of Regis Technologies, the speakers, and an overview of where an FDA 505(b)(2) fits into the regulatory pathway. Skip to the 4:00 minute mark to start the seminar.