US FDA's Presubmission Expedited Regulatory Programs Eyed For Streamlining
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.
You may also be interested in...
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.
Oncology ‘Beyond Breakthrough’ Takes Shape: FDA Project Will Create Benefits ‘Menu,’ Rescission Process
US FDA’s oncology team has come to realize that a better understanding of how to personalize its ‘all-hands-on-deck’ approach would be even more helpful – especially for first-time sponsors.
US FDA Drug Review Goals Should Be Faster In PDUFA VII, Industry Negotiators Propose
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.