Medicare Prescription Drug, Improvement, and Modernization Act of 2003
Mission
Competition
Law
Pub. L. No. 108-173, 117 Stat. 2066, codified in relevant part at 21 U.S.C. § 355(j) (Section 1102), 21 U.S.C. § 355 note (Sections 1111-1118)
Section 1102 provides that an applicant for an abbreviated new drug approval may forfeit certain exclusive marketing rights in specified circumstances, including an FTC or court determination that the...