Time To Simplify US FDA’s Expedited Pathways? It Won’t Be Simple
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.
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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.’
Agency staff, stakeholders see advantages to bundling requirements for fast-track and RMAT designations into a single, pre-breakthrough therapy pathway, and codifying processes and interactions that take place following award of breakthrough designation; proposal is aimed at reducing current programs' redundancies and maximizing benefit of frequent, early interactions with the FDA.
Regenerative Medicine In Cures: Conditional Approval Dropped In Lieu Of ‘Breakthrough’-Style Approach
Push to open up new US pathway for regenerative medicine helped the 21st Century Cures bill make it to the finish line in the lame duck Congress – but only after the proposal has been dramatically revised to fit into the established BLA pathway.