FDA’s Califf Calls For Return To Large, Simple Trials Without The ‘Useless Stuff’ That Slows Development
US FDA Commissioner Califf praises both Project Pragmatica and the ‘very powerful’ partnership between OCE Director Rick Pazdur and National Cancer Institute Director Monica Bertagnolli.
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Califf Plans US FDA, NIH Collaboration On Postmarket Evidence Generation
NIH Director Nominee Monica Bertagnolli is on board with both agencies working to better determine how approved treatments work in the real-world, FDA Commissioner Robert Califf said.
‘Anti-Aging’ R&D? One Drug To Prevent Many Diseases Is Possible, But Endpoints First Need Outside Work, FDA’s Califf Says
So-called ‘healthspan’ products would reduce the risk of multiple diseases; Califf seems open to the idea but said industry and outside groups must first find consensus on the science.
Project Pragmatica: US FDA’s OCE Initiative Aims To Encourage Simple Clinical Trials
OCE Director Richard Pazdur says idea for the latest initiative stemmed from a clinical trial in lung cancer that he thought only needed to measure the impact on overall survival.