FDA’s Woodcock Prioritizes Trial Networks As Drug Development Solution
This article was originally published in The Pink Sheet Daily
Culture change, not congressional action is needed advance this step toward faster drug development, FDA’s drug leader tells Energy & Commerce Committee.
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Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.
Called TransCelerate BioPharma, the initiative funded by 10 big drug firms will work to develop uniform clinical data standards and certification for trial sites and investigators, with deliverables expected by mid-2013.
Lumicell’s Cancer Imaging Drug Faces Clinical Meaningfulness, Anaphylaxis Risk Questions At FDA Panel
US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.