1. Federal Food, Drug, and Cosmetic Act section 505(d) (21 USC § 355(d)).
2. Public Health Services Act section 351 (42 USC § 262).
3. Section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 USC 355(d)).
4. Demonstrating substantial evidence of effectiveness for human drug and biological products. Draft Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration; 2019.
5. Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian approaches to clinical trials and health-care evaluation. Wiley, New York; 2004.