Lesson 1.2

Question 1

Drugs that are administered orally in liquid form or drugs that are administered parenterally do not go through this phase

Answer 1

Pharmaceutic Phase

Question 2

as agency of the department of health and human services

Answer 2

Food and Drug Administration 1906

Question 3

controls whether prescription and OTC drugs may be used for therapy

Answer 3

Center for Drug Evaluation and Research (CDER)

Question 4

regulates serums, vaccines and blood products

Answer 4

Center for Biologics Evaluation and Research (CBER)

Question 5

Prevents marketing of drugs not thoroughly tested

Answer 5

Food Drug and Cosmetic Act 1938

Question 6

regulates safety of biologics

Answer 6

Childhood Vaccine Act 1986

Question 7

increases research and assist person dependent on drugs with rehabilitation

Answer 7

Controlled Substance Act 1971

Question 8

requires non generic drug and biologic manufacturer to pay fees to be used for improvements in drug review

Answer 8

Prescription Drug User Fee Act 1992

Question 9

requires labeling of dietary supplement and allows FDA to remove those that are a risk to the public

Answer 9

Dietary Supplement Health and Education Act 1994

Question 10

Reauthorizes the prescription drug user fee act and reforms the drug review process

Answer 10

FDA Modernization Act 1997