How "Clean" Will PDFUA V Be? Rep. Pitts Explains His Vacuuming Technique
Pennsylvania Republican Joe Pitts, chairman of the House Energy and Commerce Health Subcommittee, has a straightforward approach to reauthorizing the Prescription Drug User Fee Act – get it done early.
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The pending Supreme Court decision on the Affordable Care Act may have forced negotiators to finish quicker than they would have liked as legislators indicate some more time may have produced an agreement on track-and-trace standards; stakeholders may question whether the bill could have been improved had the deadline not been looming.
House and Senate committee user fee bill mark-ups approaching, but drafts have differences in drug shortage, supply chain security and other proposed policy changes to reconcile.
Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain
Rep. Phil Gingrey, lead sponsor of the Generating Antibiotic Incentives Now Act, says industry still has questions about the proposed approval pathway for antibiotics treating life-threatening diseases, further clouding its prospects.