Regulatory Freelancing: Rare Disease Group Hopes To Shape FDA Guidance
EveryLife Foundation is working on a white paper that it hopes will inform FDA’s guidance clarifying accelerated approval and fast track pathways, which is mandated in FDASIA.
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Letter being circulated by Rep. Bilirakis states the agency’s draft expedited approval guidance does not provide clarity for rare disease sponsors to use accelerated approval.
Updated draft white paper on expanding use of accelerated approval suggests FDA approve the use of biomarkers as surrogate endpoints in the pre-IND stage, which could enhance sponsors’ abilities to raise funds for trials and manufacturing.
FDA official says idea could be helpful; meanwhile, sponsors and others remain concerned about the framework’s undefined decision-making methods.