Senate Updates PDUFA V Language, Plans Vote for Next Week

The Senate plans to debate and vote on an omnibus FDA user fee bill next week, as lawmakers Tuesday substituted a new bill for the prior reauthorization bill. Sens. Tom Harkin (Iowa) and Mike Enzi (Wyo.), the top Democrat and Republican on the Senate Health, Education, Labor, & Pensions (HELP) Committee, released late Tuesday the new FDA Safety and Innovation Act (S. 3187), which replaces the prior user fee bill (S. 2516) and expands it in several key areas.
Drug Industry Daily