PCL102H1 Lecture Notes - Lecture 23: Thalidomide, Morning Sickness, Health Canada
27 Apr 2016
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Pcl102 lec 23 drug approvals and the fda. Thalidomide--drug against morning sickness for pregnant women drug affected 20,000 children in canada. Frances kelsey refused approval of drug; claiming more testing needed usa spared. >proof of efficacy required for all new drugs in order to receive market approval in us. Clinical trial application (info about pis, drug dosage, preclinical tests) Company submits new drug submission to tpd (health canada) Info about drug manufacture, safety, dosage, therapeutic claims, side effects, benefits outweigh risks. Staff scientists, plus potentially external consultants and advisory committees. Tpd evaluates safety, efficacy, and quality of data (study design, statistics) Drug issued a notice of compliance and a din. Sponsor can supply additional information, re-submit later with additional data, or appeal decision. Review process usually takes ~18 months (starting when nds submitted) Act up (aids coalition to unleash power) activists presses fda to speed up aids drug approval (us)
