Bibliography
- Gaudry KS. Exclusivity strategies and opportunities in view of the Biologics Price Competition and Innovation act. Food Drug L J 2011;66:587-630; for an overview of the BPCIA
- 42 U.S.C. 262(k)(2)
- 42 U.S.C. 262(l)(2)
- 42 U.S.C. 262(l)(9)(C)
- 42 U.S.C. 262(f)
- 42 U.S.C. 262(l)(9)(B)
- 42 U.S.C. 262(l)(3)(A)
- 42 U.S.C. 262(l)(8)(B)
- 35 U.S.C 271(e)(6)(C)
- 42 U.S.C. 262(l)(3)(B)
- 42 U.S.C. 262(l)(5)(A)
- 42 U.S.C. 262(l)(5)(B)(ii)(II)
- 42 U.S.C. 262(l)(8)(A)
- 42 U.S.C. 262(l)(8)(B)
- “Trends in NDA and BLA Submissions and Approval Times”. Available from: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm209349.htm