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Califf Outlines Clinical Trial Reform Message, Which Could Travel With Him To Commissioner’s Office

US FDA commissioner-nominee Califf calls for streamlining clinical trial bureaucracy, as well as open access to clinical data.

Clinical Trials Research & Development

Janssen’s Sarich: Randomized Controlled Trials, Real-World Evidence Go Best Together

Janssen’s Troy Sarich outlines why it’s hard to emulate randomized controlled trials with real-world evidence studies, emphasizing that the two are “not in competition.” He also highlights the huge strides made by AI-driven technology firms to provide “research-ready” structured data and new game-changing advances in the area of health sensors.

Research & Development Artificial Intelligence

Califf Likely To Find Many Familiar Problems Upon Return To US FDA Helm

President Biden’s pick for FDA commissioner should remember many of the hot-button issues that he would face upon confirmation, such as drug pricing and approval standards.

FDA Executive Changes

Califf Confirmation Hearing Round Two: Industry Ties Once Again May Bark Loud, Bite Lightly

The cardiologist seeking another term as FDA commissioner has been working in the pharma industry since leaving the post, but Senators have tended not to  question nominee's work history extensively during previous confirmation hearings.

FDA Leadership
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