12:00 AM
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Jan 15, 2007
 |  BioCentury  |  Politics, Policy & Law

Enzi-Kennedy & PDUFA IV

Enzi-Kennedy & PDUFA IV

Enzi-Kennedy & PDUFA IV
Both the PDUFA IV proposal and the Enhancing Drug Safety and Innovation Act of 2006 (S. 3807) are intended to improve drug safety. S. 3807 mandates risk management strategies (REMS) for all NDAs and BLAs, supplemental approvals and many marketed drugs, and gives FDA new authority over distribution, labeling and sponsor post-market commitments. The PDUFA IV proposal beefs up FDA's ability to monitor the safety of marketed products, but gives the agency discretion over which products require more or less extensive monitoring. Sens. Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.), sponsors of S. 3807, are considering attaching provisions similar to...

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