Effective Date
[Pub. L. 112–144, title VIII, § 801(b)], July 9, 2012, [126 Stat. 1079], provided that: “Section 505E of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f], as added by subsection (a), applies only with respect to a drug that is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act [July 9, 2012].”