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Posted 21 March 2012 | By Alexander Gaffney, RAC
Health Canada is allowing unapproved drugs into the country on a short-term, controlled basis in order to alleviate recent drug shortages, reports The Ottawa Citizen.
"Under the special access program, the federal drug regulator has the power to grant the limited sale of unapproved drugs to physicians treating select patients with 'serious or life-threatening conditions,'" wrote TheOttawa Citizen.
Health Canada has reportedly approved 17 requests under the special access program, with another five requests still being processed by the agency.
Unapproved drugs are only temporarily approved for distribution if they have been approved in other countries by a "trusted regulator," including the US Food and Drug Administration (FDA), which has put in place a similar program to ease shortages of Doxil and methotrexate.
Ottowa Citizen - Sandoz says it won't price-gouge during drug shortage
Regulatory Focus - US FDA Importing Unapproved Drugs to Ease Shortages
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Regulatory Focus - Health Canada Accelerating Approvals to Ease Drug Shortages
Tags: Special Access Program, Shortages, Latest News, Drug Shortages, pharmaceutical, drug
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...