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LAW EXAM 1
| FRONT | BACK |
|---|---|
| pure food and drug act (1906) | required drugs to meet purity and strength standards |
| federal food, drug and cosmetic act (1938) | adds safety to purity and strength requirements, created the FDA - (new drug applications - NDA) efficacy still not required |
| Durham Humphrey (1951) + labeling requirements | Created 2 drug classes, prescription and over the counter efficacy still not required name and address of pharmacy, Rx #, date of prescription, name of prescriber, name of patients, directions to use |
| Kefauver harris amendments (1962) | finally requires drugs to prove efficacy as well as safety through more clinical trials |
| Drug abuse control amendments (1965) | Controlled use of depressants, stimulants and hallucinogens led to controlled substance act of 1970 |
| Medical device amendment (1976) | Safety and efficacy of medical devices |
| Orphan drug act (1983) | Offer incentives for manufacturers to research and produce drugs for forgotten or very rare disease states |
| Hatch-Waxman - drug price competition and patent restoration act (1983) | Created ANDA (abbreviated new drug application) for generics - must be bioequivalent, cuts price through competition but brand names are giving a 5 year patent |
| Orange books | primary source for identifying bioequivalents A = eq AB =. eq with resolved problems B = not eq need A or AAB for equivalent status |
| Prescriptions drug marketing act (PDMA) (1987) | no reimporting Rx, no samples, no reselling |
| FDA modernization act (FDAMA) (1997) | classifies new prescription drugs through FDA as "Rx ONLY" |
| Food and drug administration amendments act (2007) |
Created by:
beezy41