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 |
