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Pharm Drug Acts
| Question | Answer |
|---|---|
| pure food & drug act | defined adulterated & misbranded foods & drugs; prohibited shipment across state lines |
| sherley amendment | prohibited false & fraudulent curative/therapeutic claims on label; required gov't to prove intention to defraud |
| federal food, drug, & cosmetic act | new drug applications must show evidence of safety (massengill's elixer, sulfa drugs dissolved in diethylene glycol) |
| durham-humprey amendments | rx drugs dispensed by pharmacists only w/ script; separated OTC from rx |
| kefauver-harris amendments | established good manufacturing practices- sterility, cleanliness; NDA must show effectiveness & incr safety regs (winthrop's sulfathiazole tabs, bug parts & contaminants) |
| orphan drug act | incentives to develop drugs w/ small or no profit value |
| drug price competition & patent term restoration act | made generic drug entry to market easier; only had to show it has same pharmaco- properties |
| drug export act | more freedom to export unapproved product; prevent having drug manufacturing taken overseas |
| prescription drug user fee act | required manufacturers to pay fee to FDA to reg & review prods; FDA spends $ on more reviewers; win-win |
| dietary supplement health & education act | classified agents as foods; stopped disease claims in 2007 |
| food & drug administration modernization act | accelerated approval of drugs; fast track; must meet certain guidelines (imp in diseases w/out many options, help a lot of ppl) |