Adempas Review Gives First Glimpse Of FDA Benefit-Risk Framework In Action
Graphic presentation of the evidence, uncertainties, conclusions and risks of a drug could become more complex for therapies with major efficacy or safety questions.
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Looking Forward At FDA: Hamburg’s Farewell Notes Challenges; Califf’s First Remarks Focus on Pediatrics
FDA Commissioner Margaret Hamburg is leaving the agency on a high note – and taking the opportunity to urge stakeholders to avoid the temptation to push for changes that will “”weaken or undermine” the agency. Meanwhile, FDA's new Deputy Commissioner of Medical Products Robert Califf makes his first formal remarks in that role during a stakeholder meeting on pediatric research.