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Speeding The Path To Regulatory Approval In The Era Of Electronic Submissions
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<blockquote data-quote="tD33NAt" data-source="post: 2058541" data-attributes="member: 124445"><p>When a pharmaceutical company wants its new drug on the market, it must first submit mountains of paperwork to regulatory agencies like the US Food & Drug Administration (FDA)-most of it scientific articles describing the drug's properties. Gathering these articles can be time-consuming, expensive and downright exhausting. And if the company opts to submit them all electronically, there's another hurdle to clear: the regulatory agency wants all articles in the electronic Common Technical Document (eCTD) format...<a href="http://feedads.g.doubleclick.net/~a/shPN9GpW1MNTjjm6_xtjziiROCA/0/da" target="_blank"><img src="http://feedads.g.doubleclick.net/~a/shPN9GpW1MNTjjm6_xtjziiROCA/0/di" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /></a></p><p><a href="http://feedads.g.doubleclick.net/~a/shPN9GpW1MNTjjm6_xtjziiROCA/1/da" target="_blank"><img src="http://feedads.g.doubleclick.net/~a/shPN9GpW1MNTjjm6_xtjziiROCA/1/di" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /></a></p><p></p><p><img src="http://feeds.feedburner.com/~r/mnt/healthnews/~4/Dc74_1w92v4" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /></p><p></p><p><a href="http://feedproxy.google.com/~r/mnt/healthnews/~3/Dc74_1w92v4/173934.php" target="_blank">More...</a></p></blockquote><p></p>
[QUOTE="tD33NAt, post: 2058541, member: 124445"] When a pharmaceutical company wants its new drug on the market, it must first submit mountains of paperwork to regulatory agencies like the US Food & Drug Administration (FDA)-most of it scientific articles describing the drug's properties. Gathering these articles can be time-consuming, expensive and downright exhausting. And if the company opts to submit them all electronically, there's another hurdle to clear: the regulatory agency wants all articles in the electronic Common Technical Document (eCTD) format...[URL="http://feedads.g.doubleclick.net/~a/shPN9GpW1MNTjjm6_xtjziiROCA/0/da"][IMG]http://feedads.g.doubleclick.net/~a/shPN9GpW1MNTjjm6_xtjziiROCA/0/di[/IMG][/URL] [URL="http://feedads.g.doubleclick.net/~a/shPN9GpW1MNTjjm6_xtjziiROCA/1/da"][IMG]http://feedads.g.doubleclick.net/~a/shPN9GpW1MNTjjm6_xtjziiROCA/1/di[/IMG][/URL] [IMG]http://feeds.feedburner.com/~r/mnt/healthnews/~4/Dc74_1w92v4[/IMG] [url=http://feedproxy.google.com/~r/mnt/healthnews/~3/Dc74_1w92v4/173934.php]More...[/url] [/QUOTE]
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