INDEPENDENT STUDY N 137
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Dr. Kurtis Nolan
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This 10 page Class Notes was uploaded by Dr. Kurtis Nolan on Sunday September 6, 2015. The Class Notes belongs to N 137 at University of Texas at Austin taught by Staff in Fall. Since its upload, it has received 39 views. For similar materials see /class/181625/n-137-university-of-texas-at-austin in Nursing and Health Sciences at University of Texas at Austin.
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Date Created: 09/06/15
Lecture 22 FDA Regulation of New Drugs and Medical Devices Overview Drug and Device Regulation Reaction to Disaster Tragedy and Misfortune 1906 I First federal regulation of drugs Burden on FDA to PROVE it is UNSAFE 1938 Food Drug and Cosmetic Act Premarket NOTIFICATION 1962 Drug amendments to FDampC Act Premarket APPROVAL 1976 Medical Device Amendments to FDampC Act Using Gold to Detect Cancer A a Antibody A How long do you think it will be before we can test this in patients Using Gold to Feel Better 1 tittplanalcl iemistswotkshoocom a httpwwwumnacomZQClZALLPQUTICS1 2 offbeatbluecandiolate How long do you think it will be before we can test this in patients Vitamin Mineral HerbalSupplements Thousands sold in the US Remarkably little is known about most inttpl ilillivwlidncucon il productsli 6 out of 10 Americans take one or more supplements a day I Multivitamins Amino acids Weightloss cures Herbal tonics Americans spent 19 billion on dietary supplements in 2003 Zantrex 3 One of the most popular weight loss supplements currently sold in the US One month s supply 50 Millions of bottles sold Hit US market in March 2003 Sold at GNC CVS RiteAid WalMart internet eBay Contains I Caffeine Green tea Three common South American herbs that act as stimulants Found in Cosmo Glamour and Parade Discovered In Britney39s purse htt1800atchesco mzantrexcomboht mlsiteidia 259 H D 1 G4hCzo EaxIX39 D55 Hondaquot Bovtcmbw a Brunny Spurs ukcs mamw mu m mmmn m snxy m ardwu m a mum md ucwsnivm a Dvmicss was My bm39nw m mp Ymr v mm at mm m How vam y mym a Anqnhs mamm m Shaw Kruncy gvabh r um mm have quotMama g r n mm Zantrex Marketing 1 Don Atkinson VP of Sales for Basic Research Company that distributes Zantrex3 a When I train salespeople I say to them Do you know what people are calling you for It isn t the pill They are calling you for hope That is really what they want from you a I love my job And do you know why Because when I get up in the morning I know somebody s life is better because we are here Somebody today got some hope 1994 Dietary Supplement Health amp Education Act Congress deregulated supplement industry Companies are not required to prove products are effective or even safe before marketing them Companies CANNOT Blatantly lie Claim to have a cure for a specific disease cancer diabetes AIDS Companies CAN say without evidence Product is designed to support a healthy heart M Protect cells from damage Liverite Improve function of compromised immune system M Almost no standards that regulate how pills are made Not tested once they are made
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