IHS Chemical Week

EnviroTech :: Regulatory

Lawmakers Push for Enhanced FDA Oversight

2:04 PM MDT | March 12, 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 House of Representative's 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...

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