JOHANN YI-DER LIN, PH.D.

Duane Morris LLP

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FDA Publishes Redraft of 510(k) Third Party Review Program

USA - November 20 2018 Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes…

Carolyn A. Alenci, Frederick R. Ball, Lisa W. Clark, Stephen M. Honig, Jennifer A. Kearns, Vicki G. Norton, Jiazhong (Jason) Luo, Ph.D., Ryan Smith