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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...

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Experts raised concerns about the pilot program's larger than expected size and the lack of transparency about the reasons the cohort deserved vouchers over a pool that the FDA said included hundreds of candidates.

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The hiring and departure data provide more evidence of the extent of the Trump Administration’s efforts to shrink the FDA workforce through cuts and voluntary departures.

Pink Sheet Podcast: US FDA Involved In Drug Pricing Deal, DOJ’s Off-Label Promotion Policy

 
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With US FDA Adcomm Meetings Disappearing, Sponsors Seek Other Outlets For Patient Voice

 
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Formal meetings like application orientation sessions or patient listening sessions are becoming increasingly important as the FDA schedules fewer advisory committee meetings for applications, experts said.

US FDA Could Use Shutdown To Improve Amid Growing Foreign Competition

 
• By Alaric DeArment

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