US FDA's Benefit-Risk Assessment Could Include More Emphasis on Patient Involvement
Agency aims to centralize and better communicate its assessments; stakeholders discuss involving patients early in drug development and offer suggestions for 2020 draft guidance.
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Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.
Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.
Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.