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Bloomberg

The FDA's push for 'radical transparency'

Bloomberg · 1 month ago
Bloomberg
Bloomberg
1 month ago

FDA Commissioner Martin Makary says the agency will begin publishing drug rejection letters long kept confidential to help developers better understand what he calls the FDA's "black box."

Breakdown
  • The FDA will begin publishing its drug rejection letters to increase transparency. 18s
  • Previously, these letters were kept confidential, partly due to company preferences. 29s
  • Companies have sometimes misrepresented FDA feedback on drug rejections. 38s
  • Public disclosure of rejection reasons is expected to help the industry develop drugs more efficiently. 1m 0s
  • The FDA aims to move away from being a 'black box' and provide clearer guidance to developers. 1m 10s
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