The Federal Food, Drug, and Cosmetic Act [
21 U.S.C.
301 et seq.], including the requirements under sections 505(o), 505(p), and 505–1 of such Act [
21 U.S.C.
355
(o), (p),
355–1], applies to a biological product subject to regulation under this section, except that a product for which a license has been approved under subsection (a) shall not be required to have an approved application under section 505 of such Act.