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.
You may also be interested in...
Fluff Or Next Potential Discovery? FDA Wants Simpler Clinical Trials, But Not Telling Sponsors Endpoints Are Unnecessary
Some of the growing number of secondary and tertiary endpoints may not be needed, but also could fuel future products and advance science.
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.