(2) (A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. (B) Pediatric studies .— A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355c ]. (C) The Secretary shall approve a biologics license application— (i) on the basis of a demonstration that— (I) the biological product that is the subject of the application is safe, pure, and potent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (D) Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy .— A person that submits an application for a license under this paragraph is subject to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355 (o), (p), 355–1]. (E) (i) The Secretary may rely upon qualified data summaries to support the approval of a supplemental application, with respect to a qualified indication for a drug, submitted under this subsection, if such supplemental application complies with the requirements of subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(c)(5) ]. (ii) In this subparagraph, the terms “qualified indication” and “qualified data summary” have the meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.