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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Assessments of obesity drugs should look at their effects in patients grouped by health status and FDA should expand the universe of secondary endpoints available to assess benefits, a group of stakeholders says.
Group convened by George Washington University School of Public Health and Health Services recommends a “patient-centered” approach to reviewing obesity drugs that includes assessing the therapies for their risks and benefits for obese individuals who are healthy, have risk factors for co-morbidities or impairments to daily feeling or functioning, or are already sick.
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.