FDA updates rules on safety reporting in clinical trials

The US Food and Drug Administration has revised its rules on the reporting of safety information during clinical trials of investigational drugs and biologics, bringing in new measures to protect patients but also reduce the burden of regulatory oversight.

Under the new rule, trial sponsors will be required to send a notification to the agency within 15 days of becoming aware of certain safety occurrences, including findings from clinical or epidemiological studies that suggest a significant risk to study participants and serious suspected adverse reactions that occur at higher-than-expected rates.

The rule also brings tighter reporting requirements for serious adverse events from bioavailability studies, which determine what percentage and at what rate drug is absorbed by the bloodstream, and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug.