Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors
Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’
You may also be interested in...
Medicare Payment Advisory Commission also considering reviving least costly alternative policy in some way, but remains relatively hesitant about changes to ASP+6%.
Oncology center director Pazdur thinks it is time to streamline the expedited pathways for drug development in the US. Focusing on the goals, rather than the paperwork, is a good idea – but is easier said than done.
US FDA’s Oncology Center of Excellence Director and the National Institutes of Health National Cancer Institute Director defended the agency’s accelerated approval pathway, saying critics are missing the benefits reaped by many cancer patients. Pazdur worries pathway is at risk, unless champions work to counter critics.