Antibiotics Approval Changes GAINing Acceptance; PDUFA May Not Get LPADed Out
This article was originally published in The Pink Sheet Daily
Rep. Waxman is expected to bring up the Limited Population Antibacterial Drug proposal during an April 18 hearing, but it was not included in the latest House user fee discussion draft.
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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.