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Tyna Dao, Nakissa Sadrieh. A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs. Regulatory toxicology and pharmacology: RTP. 2026;165:106007. doi:10.1016/j.yrtph.2025.106007

Gail A. Van Norman. Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs. JACC: Basic to Translational Science. 2016;1(3):170-179. doi:10.1016/j.jacbts.2016.03.002