Biotech Values

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FDA Officials Talk Tough About Accelerated Approval

To prompt drugmakers to follow through more quickly on post-marketing studies required as part of the controversial acceleted approval program, several FDA officials suggest the agency make use of an existing provision of a 2007 law - issuing fines of up to $10 million. And the FDA may also require post-marketing studies get under way before expedited approval is granted, according to agency officials who floated the possibilities in a new article in the Journal of the National Cancer Institute.

http://www.pharmalot.com/2011/03/fda-officials-talk-tough-about-accelerated-approval/