Drug Development

Question 1

Which drug regulation requires manufacturers to label products as a result of opium and cocaine addictions in early medicines?

Answer 1

Pure Food and Drug act

Question 2

Which drug regulation was passed to deal with safety issues as a result of diethylene glycol in sulfa drugs?

Answer 2

Modified Food, Drug and Cosmetic Act

Question 3

Which drug regulation made a distinction between Rx and OTC?

Answer 3

Durham-Hymphrey Amendment

Question 4

What 3 things make something prescription only?

Answer 4

1-Addicting
2-Safety/toxicity concern
3-Therapeutic indications

Question 5

Which drug regulation deals with enhanced safety and efficacy because of phocomelia caused by thalidomides?

Answer 5

Kefauver-Harris Amendment

Question 6

Which drug regulation regulates herbal products and defines them as food?

Answer 6

Dietary Supplement Health and Education Act

Question 7

What does the FDA regulate?

Answer 7

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

Question 8

Who controls animal preclinical testing?

Answer 8

IACUC (Institutional Animal Care Committee)

Question 9

A small group of healthy (usually) subjects to test safety, doses, administration and other kinetics are used in what phase?

Answer 9

Phase I

Question 10

A small group of subjects with condition to be treated to test safety (still) and efficacy are used in what phase?

Answer 10

Phase II

Question 11

The extended clinical phase with a large group of subjects, using double blind construct, placebos and multi-sites groups to test for statistical efficacy is which phase?

Answer 11

Phase III

Question 12

Continued assessment and monitoring for side effects takes place in the marketing phase and is unofficially which phase?

Answer 12

Phase IV

Question 13

Who deals with the local human rights in an organization?

Answer 13

IRB (institutional review board)

Question 14

The first communication with the FDA is done via what?

Answer 14

IND (investigational new drug)

Question 15

While urgent drugs may be fast tracked, what policy is for rare disease drugs to encourage development?

Answer 15

Orphan Drug act

Question 16

What 4 criteria go into switching a drug from Rx to OTC?

Answer 16

1-Need to reduce cost
2-Prescription for 3 years before conversion to OTC status
3-Good safety record
4-Frequent use/Demonstrated need

Question 17

What are the 3 categories of nonprescription drugs?

Answer 17

1-I (safe and effective)
2-II (unsafe or ineffective)
3-III (not sure—requires more studies)

Question 18

Though not FDA approved, a drug can be used “off label” to treat another condition confirmed by ______ and _______

Answer 18

research

clinical experience

Question 19

How are herbal products treated according to the FDA?

Answer 19

Treated as food

Question 20

What policy requires listing of ingredients and serving size?

Answer 20

DSHEA (Dietary Supplement Health Education Act)

*also structure function claims