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.
Guidance, Compliance and Regulatory Information
Center for Drug Evaluation and Research, Manual of Policies and Procedures
United States Patent and Trademark Office
Utility Examination Guidelines, 66 FR 1092
Manual of Patent Examining Procedures
Revised Interim Utility Guidelines Training Materials
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)
United States Food and Drug Administration
Title 21(Food and Drugs)
Title 37 (Patents, Trademarks, and Copyrights)
The Code of Federal Regulations and Federal Register 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.
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.
 This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License. |