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