Drug Approval Process & more

Question 1

2. Clinical Investigation

Answer 1

Testing on safety and effectiveness on humans

Question 2

3. IND Review

Answer 2

Investigational new drug application submitted to FDA from drug manufacturers

Question 3

4. Post-Marketing

Answer 3

Surveillance is done by FDA, patients, doctors, and manufacturers for possible new side effects.

Question 4

1. Pre-Clinical Investigation

Answer 4

Testing on safety and effectiveness on animals

Question 5

DEA = Drug Enforcement Agency

                               REGULATES

Answer 5

Sell, manufacturing, distribution and the use

Question 6

FDA = Food and Drug Administration

Answer 6

Ensures that all pharmaceutical products ( food, drug, cosmetic and medical devices) are pure, safe, and effective.

Question 7

DEA set 5 scheduled drugs
SCHEDULE: 1

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

Answer 7

High
None
Heroine, peyote, marijuana

Question 8

SCHEDULE 2

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

Answer 8

High
Need new Rx
Morphine, hydro morphine, hydro codeine and cocain

Question 9

SCHEDULE 3

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

Answer 9

Moderate
5 refills w/ in 6 months
Tylenol#3

Question 10

SCHEDULE 4

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

Answer 10

Low
5 refills w/ in 6 months
Actonel

Question 11

SCHEDULE 5

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

Answer 11

Low
OTC
Robitussin

Question 12

Orange

Answer 12

Safety Equivalence

Question 13

Red

Answer 13

Therapeutic equivalence

Question 14

Blue

Answer 14

Bio equivalence

Question 15

454.8g =

Answer 15

1lb

Question 16

2.2K =

Answer 16

1lb

Question 17

ml —–> L

Answer 17

/ 1000

Question 18

L ——> ml

Answer 18

*1000

Question 19

kg —-> g

Answer 19

*1000

Question 20

g ——-> kg

Answer 20

/ 1000

Question 21

mg —–> g

Answer 21

/ 1000

Question 22

g ——> mg

Answer 22

*1000

Question 23

Harrison Narcotic Act 1914

Answer 23

International : national —-> use of heroin

Question 24

Durham-Humphrey Act of 1951

Answer 24

Separated drugs into two categories: legend and nonlegend (OTC)

Question 25

Kefauver-Harris Amendment of 1962

Answer 25

Requires all medications in the United States to be pure, safe, and effective

Question 26

Comprehensive Drug Abuse Prevention and Control Act 1970

Answer 26

The DEA was created and placed under the supervision of the Department of Justice.

Question 27

Pure Food and Drug Act of 1906

Answer 27

Enacted in 1906 to prohibit the interstate transportation or sale of adulterated and misbranded food or drugs

Question 28

Food , Drug, and Cosmetic Act of 1938 (FDCA 1938)

Answer 28

• The U.S Food and Drug Administration (FDA) was created under FDCA 1938
• Requires that all new drug applications be filed with the FDA
• Clearly defined adulteration and misbranding of drugs and food products

Question 29

Poison Prevention Packaging Act of 1970

Answer 29

The Poison Prevention Packaging Act of 1970 was enacted to reduce accidental poisoning in children.
***child-resistant containers