US FDA’s Science Strategies Program Aims To Proactively Tackle Drug Development Hurdles
The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.
You may also be interested in...
Five-year plan includes multi-phased approach to ALS at the same time that Amylyx’s AMX0035 is pending review with a late September decision deadline; action plan’s mid-term priorities for FY 2023-2024 include a cell and gene therapies safety project.
‘Umbrella’ program is intended to ensure all rare disease and related programs at CDER are working together, which seems similar to the rare disease center of excellence concept that stakeholders want to coordinate activities across the FDA.
Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.