Kate Rawson
Latest From Kate Rawson
‘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.
The Power Of The Public: Isotretinoin iPLEDGE Advisory Cmte. Is Case Study In An Effective OPH
Open public hearings can include both emotional patient testimony and angry, anti-industry proclamations. During the isotretinoin REMS panel, the OPH was particularly effective in making a case for easing patient access despite the risks. Will it get FDA on board?
‘Stop Fighting' US FDA On Inspections As Food Safety Overhaul Brings ‘Big Change’ To Drug Systems – Califf
Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.
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.
‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems
Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.
US FDA Open To Cell Therapy ‘Assessment Aid’ That Could Speed Development Of Next-Gen Cancer Drugs
A framework for sponsors and the FDA to discuss ways to extrapolate existing data to support a new cell therapy could cut the time to approval.