Laws

Question 1

This law required manufacturers to demonstrate safety of new drugs prior to marketing

Answer 1

Federal Food, Drug, and Cosmetic Act of 1938

Question 2

This law allows the FDA to inspect manufacturing facilities and enforce through injunctions (blocking the marketing of product)

Answer 2

Federal Food, Drug, and Cosmetic Act of 1938

Question 3

Which act defined the following key terms: drug, device, cosmetics, labeling

Answer 3

Federal Food, Drug, and Cosmetic Act of 1938

Question 4

Which amendment to the FDCA distinguished prescription from non-prescription drugs?

Answer 4

Durham-Humphrey Amendment of 1951

Question 5

Which amendment to the FDCA requires proving effectiveness premarket and tracking side effects post marketing?

Answer 5

Kefauver-Harris Amendment of 1962

Question 6

This amendment established the use of well-controlled clinical studies conducted by qualified experts and study experts are required to give their informed consent

Answer 6

Kefauver-Harris Amendment of 1962

Question 7

Which amendment allowed FDA to set cGMP for industry and mandated regular inspections of production facilities?

Answer 7

Kefauver-Harris Amendment of 1962

Question 8

Which amendment allowed the FDA to control prescription drug advertising to include accurate information about side effects?

Answer 8

Kefauver-Harris Amendment of 1962

Question 9

Which amendment controlled the marketing of generic drugs to keep them from being sold as expensive medications under new trade names?

Answer 9

Kefauver-Harris Amendment of 1962

Question 10

Is the Anti-tampering regulation the same as the Poison Prevention Packaging Act?

Answer 10

NO

Question 11

Amends the Federal criminal code to make it a Federal offense to maliciously cause or attempt to cause injury or death to any person, or injury to any business’ reputation, by adulterating a food, drug, cosmetic, hazardous substance or other product.

Answer 11

Federal Anti-Tampering Act

Question 12

Do veterinary medications fall under the definition of drug?

Answer 12

Yes

Question 13

Is the provision of education material and their information regarding dietary supplement allowed?

Answer 13

Yes, but the location of these materials is restricted - the educational materials and publications must be kept separate from dietary supplements

Question 14

The New Pregnancy/Lactation Labeling Rule includes these four components:

Answer 14

Pregnancy exposure registry
Risk Summary
Clinical considerations
Data

Question 15

(T/F) Drugs administered by a device only need approval for the drug

Answer 15

False, both need approval

Question 16

Does the FDA need a warrant to perform an inspection during business hours?

Answer 16

No

Question 17

What amendment allows the FDA to switch prescription drugs to OTC and vice versa?

Answer 17

Durham-Humphrey Amendment

Question 18

What application needs to be submitted when the manufacturer requests a switch?

Answer 18

SNDA

Question 19

A switch for one manufacturer regarding a drug applies to other manufacturers

Answer 19

False, only applies to that drug under the manufacturer

Question 20

When the FDA adds or amends an OTC monograph, does this switch apply to all products?

Answer 20

Yes

Question 21

Patents are regulated by what entity?

Answer 21

Unites States Patent and Trademark Office (USPTO) not the FDA

Question 22

Can the FDA grant exclusivity for drugs?

Answer 22

Yes