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US FDA's New Development Science Office Modeled On Modeling Office

 
• By Derrick Gingery

Commissioner Gottlieb, who worked at FDA when modeling and simulation office was created and fostered growth of the techniques, expects that new drug development science office could do the same thing for biomarkers.

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Commissioner Scott Gottlieb is hoping the US FDA can help grow biomarker development in the same way it fostered modeling and simulation practices.

To make that happen, a new Office of Drug Development Science is expected to be added as part of the reorganization and modernization of the Office of New Drugs. Gottlieb said in a talk to the J.P

The office's goal will be to "try to bring much more consistency and rigor around certain elements of drug development science that we think now are hard sciences and are more

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• By Sarah Karlin-Smith

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Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

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