‘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.
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For Lilly’s Donanemab, US FDA Commissioner Is Already Thinking About Post-Market Questions
From positive topline data to Robert Califf weighing in on the right patient population to treat with the Alzheimer’s candidate in less than a day, the drug rejected by the agency for accelerated approval earlier this year looks to make a quick comeback.
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.
Oncology Center Of Excellence Comes Of Age at US FDA
Our infographic details organizational structure and management of FDA’s first inter-center institute; five of 11 associate director positions are being filled on an acting basis.