United States Regulations


Best Pharmaceuticals for Childrens Act – Public Law 107-109 – January 2002

Federal Food, Drug, and Cosmetic Act – Public Law 113-115 – March 2013

For Historical Purposes:

Food, Drug, and Cosmetic Act – Public Law 75-717 – 1938

Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act – Public Law 87-781 – October 1962

Genetic Information Nondiscrimination Act (GINA) – Public Law 110-233 – May 2008

National Research Act – Public Law 93-348 – July 1974

Orphan Drug Act – Public Law 97-414 – January 1983

Pediatric Research Equity Act (PREA) of 2007


Department of Health and Human Services (HHS)

Center for Medicare and Medicaid Services

Food and Drug Administration

Office for Civil Rights

Office for Human Research Protections (OHRP)

Office for Research Integrity (ORI)

Department of Defense

Department of Education

Department of Justice

   Bureau of Prisons (BOP)

   National Institute of Justice (NIJ)

Environmental Protection Agency (EPA)

Office of Management and Budget (OMB)