Timely PDUFA Passage Uncertain as Senate Debate Continues, But Vote Could Come This Week

The timely passage of an omnibus FDA user fee bill is uncertain after the Senate failed to close debate on the bill late Monday, agreeing to re-open debate at 2:15 p.m. Tuesday. Lawmakers, who reported the FDA Safety and Innovation Act (S. 3187) out of the Senate health committee in late April with broad support, still hope to have a bill ready to be signed into law before the July 4 holiday. Current authorization of the Prescription Drug User Fee Act (PDUFA) expires Sept. 30.
Drug Industry Daily