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Pharm Drug Acts

QuestionAnswer
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)
Created by: Brittina
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