1. Federal Food, Drug, and Cosmetic Act (“FDCA”), § 505, 21 U.S.C. § 355 (2020).
2. U.S. Food and Drug Administration. Guidance for Industry: REMS: FDA's Application of Statutory Factors in Determining When a REMS Is Necessary, https://www.fda.gov/media/100307/download [accessed 14 Apr. 2021].
3. New drug, antibiotic, and biological drug product regulations; accelerated approval, final rule;Fed. Reg.,1992
4. Approval With Restrictions to Assure Safe Use, 21 C.F.R. § 314.520 (2020).
5. Approval With Restrictions to Assure Safe Use, 21 C.F.R. § 601.42 (2020).