prior consent requirement
(4) In this subsection: (A) The term “relevant FDA regulations” means the regulations promulgated under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ). (B) The term “prior consent requirement” means the requirement included in the relevant FDA regulations pursuant to section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i)(4) ).