Policy, Regulations

Question 1

An authorized generic is a drug that is produced by the brand company under the NDA but marketed
as a generic, and a regular generic is produced under an —

Answer 1

Abbreviated New Drug App; ANDA

Review and approval of generic drug product

Question 2

When should an investigational new drug application (INDA) be submitted?

Answer 2

New drug, new indication or an off-label use

Question 3

What is a new drug application used?

Answer 3

New pharmaceutical for sale and marketing in the US

Question 4

What did the Pure Food and Drug Act state?

Answer 4

1. Prohibit interstate commerce of adulterated or misbranded drugs
2. Require labeling of selected dangerous and addictive substances
3. Identify USP and NF as the official standards for drugs

Question 5

What is the biggest impact of the Durham-Humphrey Amendment?

Answer 5

Differentiate prescription and nonprescription drugs

Question 6

What did the Kefauver-Harris Amendements state?

Answer 6

1. Establish requirement for drug firms to demonstrate efficacy as well as safety
2. Obtain informed consent for research subjects
3. Establish good manufacturing practices

Question 7

What did the Hatch-Waxman Act state?

Answer 7

Establish abbreviated pathway through the ANDA for generic drugs

Question 8

What the required criteria to establish pharmaceutical equivalents?

Answer 8

Same active ingredient, same dosage form, route of administration and strength/concentration