Q1

Question 1

Regulations and guidelines enforced by the FDA to assure proper design, monitoring, and control of manufacturing processes and facilities are known as:

cgmps
CGMPS
Current Good Manufacturing Practices
cGMPS
Good Manufacturing Practices

Answer 1

cGMPS

Question 2

Vioxx was an arthritis pill linked to strokes and heart problems.

True
False

Answer 2

True

Question 3

A horse named ____________was used to produce a diphtheria antitoxin led to the deaths of children due to being contaminated with Tetanus. This was the catalyst behind the Biologics Control Act of 1902 which required pre-market approval for biologics.

Maximus
Jim
Black Stallion
Montana
Seabiscuit

Answer 3

Jim

Question 4

Drug companies are required to conduct studies of drugs that have already been FDA approved and available to consumers under which legislation?

Kefauver-Harris Amendment
Biologics Control Act
FDA Amendment Act
Medical Device Regulation Act
Federal Food Drug and Cosmetics Act

Answer 4

FDA Amendment Act

Question 5

This department is known for inspecting manufacturing establishments and providing annual licenses to establishments that manufacture a biological product.

FDA
DEA
Treasury Department
Department of Human Biological Testing
Center for Devices and Radiological Health

Answer 5

Treasury Department

Question 6

The Bureau of Chemistry which was under the US Department of Agriculture is now known as:

Government Accountability Office (GAO)
The Biologics Center
Food and Drug Administration (FDA)
Food Drug and Insecticide Administration (FDIA)
National Institutes of Health (NIH)

Answer 6

Food and Drug Administration (FDA)

Question 7

Which of these writings shed light on the meat packing industry and was written by Upton Sinclair?

The Greatest Trust in the World
The Great American Fraud
The Uprising of the Many
Colliers Magazine
The Jungle

Answer 7

The Jungle

Question 8

The Wiley Act also known as _____________________was the first federal law to regulate food and drugs.

Federal Food Drug and Cosmetics Act of 1938
Drug Importation Act of 1848
The Biologics Act of 1902
Pure Food and Drug Act of 1906
The Kefauver-Harris Amendments of 1962

Answer 8

Pure Food and Drug Act of 1906

Question 9

_________________sets state-of-the-art standards to ensure the quality of medicines​

Food and Drug Administration (FDA)
International Council for Harmonisation (ICH)
US Customs and Border Protection
U.S. Pharmacopeia (USP)
Government Accountability Office (GAO)

Answer 9

U.S. Pharmacopeia (USP)

Question 10

What was the name of the device responsible for the crisis that led to infections and some abortions. In your own words, share details of the issues that were caused by the device AND name the legislation that resulted from this incident.

Answer 10

Dalkon Shield’s intrauterine device caused bacteria to be exposed to the uterus. This caused infections in that area and led to some abortions, and even infertility in some women. Some of the victims sued Dalkon Shield because of the issues their devices caused. The legislation that passed because of this event was the Medical Device Regulation Act of 1976. This amendment was added to the Federal Food, Drug, and Cosmetic Act