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The FDA and the University of Maryland Center for Regulatory Science and Innovation (MCERSI) held a public workshop to address challenges surrounding access to new medications for children and adolescents with polyarticular juvenile idiopathic arthritis (pJIA). Stakeholders discussed the need for expedited drug development, closer collaboration between all stakeholders, and the appropriate use of innovative approaches to pJIA therapeutics development and pediatric extrapolation. Long-term safety assessment was also identified as a pressing concern requiring consistent post-marketing long-term follow-up.
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