Pediatric Exclusivity Breaks 3-Month Cap In House, But Still Must Find Offset
Executive Summary
The legislation to renew the pediatric exclusivity language in the House now provides six months for all products as opposed to the sales-tiered incentives in the Senate bill, but the more generous offer serves to underline the challenge to the program - finding an offset to pay for it
You may also be interested in...
Pediatric Reauthorization In Senate Hits Pothole From Cost Offset For Exclusivity
A BPCA/PREA reauthorization bill in the Senate is similar to a bi-partisan House bill that has been incorporated into House Energy and Commerce Committee Republicans’ discussion draft of comprehensive user fee legislation, but Senate HELP committee drafters appear to need to find a “pay-for” before including the provisions.
FDA Reform Bills Grow Similar As House/Senate Conference Committee Nears
The recently passed House FDA reform bill (H.R. 2900) includes several last-minute changes that bring it closer to the Senate version (S. 1082), suggesting Congressional efforts to ease the prospective merge of the bills in the upcoming Conference Committee
FDA Reform Bills Grow Similar As House/Senate Conference Committee Nears
The recently passed House FDA reform bill (H.R. 2900) includes several last-minute changes that bring it closer to the Senate version (S. 1082), suggesting Congressional efforts to ease the prospective merge of the bills in the upcoming Conference Committee