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FDA 505(b)(2) Applications Seminar Part III: Developing a 505(b)(2) Application



May 16, 2016

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  • 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. Watch this segment for Dr. Srinivasan's key action steps on what information to reference and three critical questions when developing a 505(b)(2) application.

    Drug Discovery

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