1. 21 CFR312, Code of Federal Regulations. Title 21: Food and Drugs, Subchapter D: Drugs for Human Use, Part 312: Investigational New Drug Application.
2. 21 CFR314, Code of Federal Regulations. Title 21: Food and Drugs, Subchapter D: Drugs for Human Use, Part 314: Applications for FDA Approval to Market a New Drug.
3. 21 CFR601, Code of Federal Regulations. Title 21: Food and Drugs, Subchapter F: Biologics, Part 601: Licensing.
4. 21 U.S.C. 355, United States Code, Title 21 - Food and Drugs, Chapter 9 - Federal Food, Drug, and Cosmetic Act, Subchapter V - Drugs and Devices, Part A - Drugs and Devices, Sec. 355 - New Drugs.
5. An FDA/CDER perspective on nonclinical testing strategies: classical toxicology approaches and new approach methodologies (NAMs);Avila;Regul. Toxicol. Pharmacol.,2020