“Complete Response” Letters Might Include Benefit-Risk Framework Discussion
FDA official says idea could be helpful; meanwhile, sponsors and others remain concerned about the framework’s undefined decision-making methods.
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Early discussions based on the framework could engender more efficient drug reviews and aid industry in decisions on clinical programs, BIO and PhRMA note in comments to the agency.
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.