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 <title>Jeol Lexchin</title>
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 <title>Canada&#039;s streamlined approval process raises protests</title>
 <link>http://www.fiercebiotech.com/story/canada-s-streamlined-approval-process-raises-protests/2008-04-09?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FB0</link>
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Canadian officials are batting down critics who say that the country&#039;s new, streamlined drug approval process will let unsafe therapies onto the market. The dispute centers on Canada&#039;s new standard for drug approval: The benefits offered by a new drug have to outweigh the harm it does. And critics see the shift as a significant retreat from earlier safety standards. The changes come as Health Canada adopts a &amp;quot;progressive licensing&amp;quot; approach, which calls for ongoing trials both before and after approvals to judge the safety of new therapies.
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&lt;p&gt;
&amp;quot;I think that&#039;s a pretty dangerous thing to be doing,&amp;quot; Joel Lexchin, a health policy professor at York University and drug safety expert tells the &lt;em&gt;Globe and Mail&lt;/em&gt;. &amp;quot;This is part of a general trend in a lot of countries, at least with respect to the drug-approval system, [which] is deregulation, turning over more responsibility to the drug companies.&amp;quot;
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- read the &lt;a href=&quot;http://www.theglobeandmail.com/servlet/story/RTGAM.20080409.wsafetyside09/BNStory/National/home&quot;&gt;article&lt;/a&gt; in the &lt;em&gt;Globe and Mail&lt;/em&gt;
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&lt;strong&gt;Related Articles:&lt;br /&gt;
&lt;/strong&gt;Canadian regulators forging new &lt;a href=&quot;http://www.fiercebiotech.com/story/canadian-regulators-forging-new-biosimilar-pathway/2008-03-25&quot;&gt;biosimilar&lt;/a&gt; pathway&lt;strong&gt;&lt;br /&gt;
&lt;/strong&gt;Canada&#039;s &lt;a href=&quot;http://www.fiercepharma.com/story/also-noted-canadas-drug-market-slowing-gsk-files-promacta-approval/2007-12-20&quot;&gt;drug market&lt;/a&gt; slowing
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 <comments>http://www.fiercebiotech.com/story/canada-s-streamlined-approval-process-raises-protests/2008-04-09#comments</comments>
 <category domain="http://www.fiercebiotech.com/tags/drug-approvals-0">Drug approvals</category>
 <category domain="http://www.fiercebiotech.com/tags/drug-safety">Drug Safety</category>
 <category domain="http://www.fiercebiotech.com/tags/health-canada-0">Health Canada</category>
 <category domain="http://www.fiercebiotech.com/tags/jeol-lexchin">Jeol Lexchin</category>
 <category domain="http://www.fiercebiotech.com/tags/officials">Regulators</category>
 <pubDate>Wed, 09 Apr 2008 06:59:55 -0400</pubDate>
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