FDA 505(b)(2) Applications Seminar Part II: The Regulatory Pathway

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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. Watch this segment for Dr. Srinivasan's examples of and differentiation between 505(b)(1), 505(b)(2), and 505(j) applications.