FDA 505(b)(2) Applications

April 1, 2020

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.

Select a video from the collection below:

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

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

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

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

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

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

FDA 505(b)(2) Applications Seminar Part V: Quiz Time Can you identify a (b)(2) Application?

FDA 505(b)(2) Applications Seminar Part VI: Recent Statistics on 505(b)(2) NDAs

FDA 505(b)(2) Applications Seminar Part VII: Case Studies on 505(b)(2) Applications

FDA 505(b)(2) Applications Seminar Part VIII: Q&A and Discussion of 505(b)(2) Applications