Study Set Content:
causes phocomelia to the baby
Thalidomide
purpose of the enactment was to ensure a greater degree of safety for approved drugs, and manufacturers were now required to prove a drug both safe and effective before it would be granted FDA approval for marketing.
Kefauver-Harris Amendments of 1962
IND MEANING
Investigational new drug application
Issue: Thalidomide - causes phocomelia to the baby
Investigational new drug application (IND
Kefauver-Harris Amendments of 1962
• Established five schedules for drugs subject to abuse
Comprehensive Drug Abuse Prevention and Control Act of 1970
Comprehensive Drug Abuse Prevention and Control Act of 1970
CONSOLIDATES:
Drug Abuse Control Amendments of 1965 – Harrison Narcotic Act of 1914 – Other laws
Established five schedules for drugs subject to abuse
agency
DEA
No accepted medical use: high abuse potential
Schedule I
Accepted medical use: less abuse potential than II leading to moderated psychological or physical dependence
Schedule III
Accepted medical use: high abuse potential leading to severe psychological or physical dependence
Schedule II
Accepted medical use: low potential for abuse relative to IV: may lead to limited psychological or physical dependence
Schedule V
Accepted medical use: low potential for abuse relative to III: may lead to limited psychological or physical dependence
Schedule IV
FDA Pregnancy Categories
CATEGORY A, B, C,D,X
Birth defect or mental retardation rate is(blank) to (blank) in the general population.
3% to 5%
Stage of pregnancy and the amount of medication taken
Stage of pregnancy and the amount of medication taken
Evaluate each patient individually for an accurate risk assessment.
Evaluate each patient individually for an accurate risk assessment.
Teratogens:
Radiation – Infections – Maternal and metabolic imbalance – Drugs and environmental chemicals
FDA’s strongest labeling requirements for high-risk medicines
Black Box Warnings
Most serious warning placed in the labelling of a prescription medication
Black Box Warnings
was the first issued with a Black box warning
Chloramphenicol
