1. Federal Food, Drug, and Cosmetic Act section 506(c)(1)(A); 21 U.S.C. § 356(c)(1)(A).
2. Federal Food, Drug, and Cosmetic Act section 505(d), 21 U.S.C. §§ 355(d) & Federal Food, Drug, and Cosmetic Act section 506(c)(1)(A), 21 U.S.C. § 356(c)(1)(A). See also FDA Guidance for Industry, “Expedited Programs for Serious Conditions – Drugs and Biologics” (2014), at 19 (“Drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.”). See also U.S. FDA Draft Guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (December, 2019), Section II.A.
3. Guidance for Industry, “Expedited Programs for Serious Conditions – Drugs and Biologics” (2014), at 17. (“For purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.”)
4. FDA Guidance for Industry, “Expedited Programs for Serious Conditions – Drugs and Biologics” (2014).
5. FDA Postmarket Requirements and Commitments Page https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm.