Drug Approval Process & more Flashcards by Michelle Luna

Q

Clinical Investigation

A

Testing on safety and effectiveness on humans

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Q

IND Review

A

Investigational new drug application submitted to FDA from drug manufacturers

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Q

Post-Marketing

A

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

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Q

Pre-Clinical Investigation

A

Testing on safety and effectiveness on animals

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Q

DEA = Drug Enforcement Agency

                               REGULATES

A

Sell, manufacturing, distribution and the use

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Q

FDA = Food and Drug Administration

A

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

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Q

DEA set 5 scheduled drugs
SCHEDULE: 1

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

A

High
None
Heroine, peyote, marijuana

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Q

SCHEDULE 2

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

A

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

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Q

SCHEDULE 3

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

A

Moderate
5 refills w/ in 6 months
Tylenol#3

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Q

SCHEDULE 4

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

A

Low
5 refills w/ in 6 months
Actonel

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Q

SCHEDULE 5

ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:

A

Low
OTC
Robitussin

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Q

Orange

A

Safety Equivalence

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Q

Red

A

Therapeutic equivalence

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Q

Blue

A

Bio equivalence

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Q

454.8g =

A

1lb

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Q

2.2K =

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A

1lb

Q

ml —–> L

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A

/ 1000

Q

L ——> ml

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A

*1000

Q

kg —-> g

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A

*1000

Q

g ——-> kg

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A

/ 1000

Q

mg —–> g

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A

/ 1000

Q

g ——> mg

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A

*1000

Q

Harrison Narcotic Act 1914

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A

International : national —-> use of heroin

Q

Durham-Humphrey Act of 1951

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A

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

Kefauver-Harris Amendment of 1962

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

Comprehensive Drug Abuse Prevention and Control Act 1970

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

Pure Food and Drug Act of 1906

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

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

- 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

Poison Prevention Packaging Act of 1970

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