FDA and Related Regulatory Agencies Flashcards

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0
Q

Federal Food, Drug and Cosmetic Act of 1938

A

(FD&C Act) gave FDA the authority to oversee food drugs and cosmetics.

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1
Q

Food and Drug Act of 1906

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Known as the Wiley Act after Dr. Harvey W. Wiley “father” of the US food and drug law.

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2
Q

Family Smoking prevention and Tobacco Control Act of 2009

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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.

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3
Q

Vaccine Act of 1813

A

One of the first federal laws dealing with consumer protection and therapeutic substances.

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4
Q

Federal Advisor Committee Act of 1972

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5
Q

Federal Trade Commission Act of 1914

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Prohibits unfair or deceptive act or practices in or affecting commerce.

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6
Q

Heath Insurance Portability and Accountability Act of 1996

A

CMS has jurisdiction over HIPAA - creates a national standard for protecting the privacy of patients’ personal health information

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7
Q

Consumer Product Safety Act of 1972

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CPSC - ensue the safety of consumer goods, such as household appliances (except those that emit radiation), paint, child-resistant packages and baby toys.

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8
Q

Occupational Safety and Health Act f 1970

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OSHA - prevent work-related injuries, illnesses and deaths by issuing and enforcing rules for workplace safety and health.

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9
Q

Federal Alcohol Administration Act of 1935

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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.

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10
Q

Poultry Products inspection Act of 1957

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PPIA - define the term “poultry” as any domesticated bird (ducks, geese, chickens and turkeys)

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11
Q

Safe Drinking Water Act of 1974

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SDWA - turned over jurisdiction to EPA rather than FDA

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12
Q

NIH

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National Institutes of Health

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13
Q

CDC

A

Centers for Disease Control

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14
Q

CMS

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Center for Medicare and Medicaid Services

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15
Q

DHHS

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Department of Health and Human Services - FDA is part of this principal agency of the US government

16
Q

CDER

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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.

17
Q

CBER

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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.

18
Q

CDRH

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Center for Devices and Radiological Health - ensures new medical deices are safe and effective before they are marketed