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FDA considers annual clinical trials safety report

Pharma Compliance Alert, August 13, 2008

New FDA draft guidance would change the way clinical trial sponsors report safety data.

The annual development safety update reports (DSURs) would replace reports currently used to track the safety of investigational drugs. In the new report, sponsors would:

• Update the trial’s status
• Summarize their understanding and management of identified and potential risks
• Describe new safety concerns that could affect the protection of trial subjects
• Examine whether the information collected during the previous year fits with knowledge about the product’s safety

Clinical trials sponsors can provide information based on safety findings, serious adverse reactions, and relevant published articles in periodic safety updates for marketed products involved in current clinical trials, according to the guidance.

While the guidance focuses on investigational trials, the FDA also recommends sponsors report other findings regarding product safety.

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