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6:56 PM
Jun 07, 2007
 |  BC Extra  |  Top Story

House PDUFA drafts posted

The House Energy and Commerce Committee posted discussion drafts of legislation reauthorizing PDUFA, medical device user fees and incentives for conducting pediatric trials of approved drugs. The committee also posted drug safety, clinical trials registry, and conflict of interest legislation that it intends to combine with the reauthorization bill.

The drug safety legislation is similar to early drafts of the FDA Revitalization Act (FDARA) that the Senate passed in May....

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