The FDA is now proposing a change to the way safety is reported on in respect to clinical trials. The FDA is proposing that clinical trial sponsors submit an annual Development Safety Update Report (DSuR), as reported by FDA News. This would replace current reports that deliver the status of the safety of drugs in clinical trials such as the IND Annual Report.
In this new DSUR, trial sponsors would be responsible for:
--updating the trial’s status
-- summarizing their understanding and management of identified and potential risks
--describing new safety concerns that could affect the protection of trial subjects
--examining whether the information collected during the previous year fits with knowledge about the product’s safety, the draft says.
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