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.
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ALS Drugs: FDA May Adjust Development Recommendations In Real Time For Ongoing Programs
Agency’s action plan for rare neurodegenerative diseases maps out over five years, but knowledge gained can inform products currently in development; new FDA grant program looks to invest in remote use of clinical outcome assessments for amyotrophic lateral sclerosis.
US FDA’s ALS Science Strategy Includes Near-Term Rare Neurodegenerative Disease Task Force
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.
Don’t Call It A Center Of Excellence: Accelerating Rare Disease Cures Program Launched By CDER
‘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.