FDA 505(b)(2) Applications Seminar Part IV: The Thin Line between a 505(j) and 505(b)(2)

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May 16, 2016

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 advice on using the 505(b)(2) as an alternative to the 505(j) and how the 505(b)(2) measures up to generic submissions.

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