Drug Approval Process & more Flashcards
- Clinical Investigation
Testing on safety and effectiveness on humans
- IND Review
Investigational new drug application submitted to FDA from drug manufacturers
- Post-Marketing
Surveillance is done by FDA, patients, doctors, and manufacturers for possible new side effects.
- Pre-Clinical Investigation
Testing on safety and effectiveness on animals
DEA = Drug Enforcement Agency
REGULATES
Sell, manufacturing, distribution and the use
FDA = Food and Drug Administration
Ensures that all pharmaceutical products ( food, drug, cosmetic and medical devices) are pure, safe, and effective.
DEA set 5 scheduled drugs
SCHEDULE: 1
ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:
High
None
Heroine, peyote, marijuana
SCHEDULE 2
ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:
High
Need new Rx
Morphine, hydro morphine, hydro codeine and cocain
SCHEDULE 3
ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:
Moderate
5 refills w/ in 6 months
Tylenol#3
SCHEDULE 4
ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:
Low
5 refills w/ in 6 months
Actonel
SCHEDULE 5
ABUSE POTENTIAL:
Rx REQUIREMENT:
DRUG EXAMPLE:
Low
OTC
Robitussin
Orange
Safety Equivalence
Red
Therapeutic equivalence
Blue
Bio equivalence
454.8g =
1lb
2.2K =
1lb
ml —–> L
/ 1000
L ——> ml
*1000
kg —-> g
*1000
g ——-> kg
/ 1000
mg —–> g
/ 1000
g ——> mg
*1000
Harrison Narcotic Act 1914
International : national —-> use of heroin
Durham-Humphrey Act of 1951
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
