United States Code (FDSYS)
America Invents Act, Pub. L. 112-29 (2011).
Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (Hatch-Waxman Act).
Biologics Price Competition and Innovation (BPCI) Act of 2009, Pub. L. No. 111-148.
Patient Protection and Affordable Care Act, Pub. L. No. 111-148.
The United States Code, United States Statutes at Large, U.S. Federal Legislative History, and U.S. Congressional Documents Libraries are also available for FSU College of Law students through HeinOnline. Sign in for Off-campus access if you are not within the CoL complex.
Center for Drug Evaluation and Research, Manual of Policies and Procedures
Utility Examination Guidelines, 66 FR 1092
U.S. Department of Health and Human Services
Office of the Assistant Secretary for Planning and Evaluation, Economic Analysis of the Causes of Drug Shortages (Oct. 2011)
Title 21(Food and Drugs)
Title 37 (Patents, Trademarks, and Copyrights)
Regulations.gov contains agency and publicly submitted documents that are useful in understanding the perspective on pending and promulgated rules of the agencies and other participants in the rule-making process.
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