Pink Sheet Podcast Special: Assessing US FDA Advisory Committee Reform Proposals
Pink Sheet reporters and editors and special guests from 3D Communications, a firm that helps sponsors prepare for advisory committee meetings, dig into the advisory committee reform debate and discuss the impact of ideas like eliminating or reducing the number of votes.
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FDA Panel Will Have To Weigh Pediatric Cancer Drug’s ‘Higher Level’ Of Uncertainty Against Rare, Devastating Disease
US WorldMeds NDA package for eflornithine for high-risk neuroblastoma provides “a higher level of uncertainty than is typically seen in oncology applications,” agency says. Though FDA seems largely satisfied with the sponsor’s externally controlled study, confirmatory evidence may be lacking.
Obesity drug ≠ weight-loss drug, a new Pfizer-funded white paper argues in laying out a legal case for Part D coverage of obesity medicines even without legislation. Advocates hope forthcoming updates to a 2007 FDA guidance on weight management drugs will bolster the case for coverage.
Litany of deficiencies, including product quality shortcomings and a failed Phase III clinical efficacy study, may make it impossible for the agency to exercise the type of flexibility it has with the approval of other treatments for ALS and neurodegenerative diseases.