Home » New Rule on Reporting Adverse Events Should Reduce Overreporting of Data
New Rule on Reporting Adverse Events Should Reduce Overreporting of Data
To reduce the overreporting of adverse events in drug trials, the FDA has issued a final rule that clarifies when and what events sponsors should report. The overreporting of uninformative individual adverse events, often without comparative data, drains the agency’s resources and often complicates and delays its ability to detect a safety signal, the agency said.
Clinical Trials Advisor
Clinical Trials Advisor
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