FDA and Related Regulatory Agencies Flashcards
Federal Food, Drug and Cosmetic Act of 1938
(FD&C Act) gave FDA the authority to oversee food drugs and cosmetics.
Food and Drug Act of 1906
Known as the Wiley Act after Dr. Harvey W. Wiley “father” of the US food and drug law.
Family Smoking prevention and Tobacco Control Act of 2009
FDA responsibilities under this law include establishing performance standards, performing premarket review for new and modified risk tobacco products, reviewing labeling and establishing and enforcing advertising and promotion restrictions.
Vaccine Act of 1813
One of the first federal laws dealing with consumer protection and therapeutic substances.
Federal Advisor Committee Act of 1972
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Federal Trade Commission Act of 1914
Prohibits unfair or deceptive act or practices in or affecting commerce.
Heath Insurance Portability and Accountability Act of 1996
CMS has jurisdiction over HIPAA - creates a national standard for protecting the privacy of patients’ personal health information
Consumer Product Safety Act of 1972
CPSC - ensue the safety of consumer goods, such as household appliances (except those that emit radiation), paint, child-resistant packages and baby toys.
Occupational Safety and Health Act f 1970
OSHA - prevent work-related injuries, illnesses and deaths by issuing and enforcing rules for workplace safety and health.
Federal Alcohol Administration Act of 1935
FAAA - provides for federal regulation of beer, wine and distilled spirits. requirements for packaging used to hold alcohol over and above those imposed by FDA for foods under the FD&C Act.
Poultry Products inspection Act of 1957
PPIA - define the term “poultry” as any domesticated bird (ducks, geese, chickens and turkeys)
Safe Drinking Water Act of 1974
SDWA - turned over jurisdiction to EPA rather than FDA
NIH
National Institutes of Health
CDC
Centers for Disease Control
CMS
Center for Medicare and Medicaid Services
DHHS
Department of Health and Human Services - FDA is part of this principal agency of the US government
CDER
Center for Drug Evaluation and Research - regulates prescription and other-the-counter drugs, including therapeutic biologics and generic drugs throughout the product lifecycle to ensure they are safe and effective.
CBER
Center for Biologics Evaluation and Research - regulates biological products for disease prevention and treatment including vaccines, protein-based products such as monoclonal antibodies and cytokines, and blood and blood products such as plasma, blood-derived proteins, tests used to screen blood donors and devices used to make blood products.
CDRH
Center for Devices and Radiological Health - ensures new medical deices are safe and effective before they are marketed
