Drug development

Question 1

Pure Food and Drug Act
caused by
Requires what

Answer 1

caused by addiction to opium and cocaine

Requires labeling patent medicines

Question 2

Modified Food, Drug and Cosmetic Act
Caused by
Requires what

Answer 2

caused by diethyleneglycol (anitfreeze) tragedy

Required safety

Question 3

Durham-Humphrey Amendment
Caused by
Requires

Answer 3

caused by many new drugs, prescription and OTC

Required - prescription drugs, labeled as more addictive, more toxic and serious

Question 4

Kefauver-Harris Amendment
Caused by
Requires what

Answer 4

caused by Thalidomide, which causes phocomelia

Requires safety and efficacy

Question 5

Dietary supplement health and education act
Caused by
Requires

Answer 5

Regulates herbal products

Requires herbal products to be defined as foods

Question 6

Distinction between prescription and OTC drugs

Answer 6

Addiction/abuse liability
Relative safety
Intent of use - does it require professional input/control

Question 7

What all does FDA regulate

Answer 7

Foods, dietary supplements, bottled water, food additives, drugs, biologics, medical devices, cosmetics, veterinary products, tobacco products, advertising of these

Question 8

Phases of Drug testing

Answer 8

Animal preclinical testing
Phase I, II, III
Marketing (phase IV)

Question 9

Phase I of drug testing

Answer 9

small group of healthy subjects to test safety, doses, administration and other kinetics

Question 10

Phase II of drug testing

Answer 10

small group of subjects with condition to bet treated to test safety and efficacy

Question 11

Phase III of drug testing

Answer 11

Extended clinical phase, large group of subjects, using double blind construct, placebos and multi-sites group to test for statistical efficacy

Question 12

Marketing (phase 4)

Answer 12

see how the product does in production

Question 13

IRB
NDA
IND

Answer 13

Institutional review board
New drug application
Investigational new drug

Question 14

Orphan Drug Act

Answer 14

for rare disease to encourage drug development

Question 15

Fast track

Answer 15

shorten FDA approval time for urgent situations like AIDS

Question 16

Switching policy of FDA, from Rx to OTC

Answer 16

Based on need to reduce cost
New drugs are always made prescription for at least 3 years before considering their conversion to OTC status
Good safety record
Used frequently to demonstrate a need

Question 17

Non-prescription drug categories

Answer 17

I - safe and effective
II - unsafe or ineffective
III - not sure, requires more studies

Question 18

On and off

Answer 18

not FDA approved, but confirmed by research and clinical experience
label use of prescriptions

Question 19

FDA policy regarding herbal products

Answer 19

treats them as dietary supplements or food

Question 20

Labeling requirements for herbals

Answer 20

These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease

Question 21

Labeling of herbals controlled by

Answer 21

FTC - Federal Trade Commission