Expedited Approval Pathway Concept Draws Strong Support But Different Proposals
Debate at a recent cancer research meeting reflects the challenges that lay ahead, and the diverging viewpoints that will have to be balanced, in creating any new approval mechanism.
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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.
In an interview, Margolis Center for Health Policy's Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI.
Advantages could be shorter review times and expanded labels, but there are concerns about no global regulator having access to full patient-level data.