IHS Chemical Week

EnviroTech :: Regulatory

Socma: House Bill Would Streamline FDA Drug Safety Efforts

March 5, 2012 | Kara Sissell

Several U.S. lawmakers have introduced a bill that would result in more resources for FDA officials to conduct inspection of overseas drug ingredient manufacturers. The terms of the Generic Drug and Biosimilar User Fee Act have been a long-standing priority for Socma, which has a bulk pharmaceutical task force working on the issue. Socma says up to 40% of U.S. pharmaceuticals and up to 80% of drug intermediates are imported.   One of the goal’s of the bipartisan bill is to reduce the amount of time that it takes FDA to approve new drugs, from...

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