Term
| Categories of Safety in Pregnancy |
|
Definition
A: No risk to fetus
B: Risk observed in animals
C: Adverse effects in animals
D: Possible human fetal risk
X: Known fetal abnormalities |
|
|
Term
|
Definition
| Prevented mislabeling and adulteration and created the FDA. Later the drug was amended to prevent false advertising. |
|
|
Term
| Food, Drug and Cosmetic Act |
|
Definition
| Safety and prity based upon USP and NF criteria enforced by the FDA. |
|
|
Term
| Durham-Humphrey amendment to Food, Drug and Cosmetic Act |
|
Definition
| FDA permitted to determine OTCs |
|
|
Term
| Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act |
|
Definition
| Required proof of efficacy and safety |
|
|
Term
| Drug Price Competition and Patent Restoration Act |
|
Definition
| Abbreviated generic applications required bioequivalence and extended patent life |
|
|
Term
|
Definition
| Incentives for drugs targeting diseases affecting <200k in US |
|
|
Term
| Expedited Drug Approval (AIDs Epidemic) |
|
Definition
| Accelerated approval for drugs of HIGH medical need |
|
|
Term
| Presciption Drug User Fee |
|
Definition
| Manufactureres pay user fees for certain applications. This happened so the FDA could hire more people to check safety/efficacy of drugs quicker |
|
|
Term
| Dietary Supplement Health and Education Act |
|
Definition
| Amended 1958 Food Additive Act to regulate dietary supplements as foods. Is the only current legislation regulating herbal medicines and dietary supplements |
|
|
Term
| Public Health Security and Bioterrorism Preparedness and Response Act |
|
Definition
| Enhanced controls of dangerous biological agents and chemical toxins |
|
|
Term
| Best Pharmaceuticals for Children Act/Pedicatric Research Equity Act |
|
Definition
| First legislation to promote research on drug efficacy and safety in CHILDREN |
|
|
Term
|
Definition
| Expanded FDA mission to include rigorous oversight of drug safety AFTER a drug was approved (i.e. increased authority for postmarketing surveillance) |
|
|
Term
|
Definition
| Established regulations for use of opium, opiates and cocaine |
|
|
Term
| Comprehensive Drug Abuse Prevention and Control Act |
|
Definition
Drug Schedules I II III IV and V
Established programs for prevention and treatment
|
|
|
