2013
DOI: 10.1016/j.jval.2013.08.247
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HIV Regulatory Practices and Their Influence Over Reimbursement Decisions

Abstract: A365for the FDA, EMA, Health Canada and Australia the Australian Therapeutic Goods Administration. The studies used to make regulatory decisions were then compared to the studies used in the reimbursement decisions of France, Scotland, Canada and Australia. Results: In all 15 cases reviewed the FDA, EMA and Health Canada used at least one of the same studies to come to their decision and in 13 of the cases Australia also used that same study. In 14 cases the FDA approved the drug before the other regulatory au… Show more

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