FDA issues final rule on safety information during clinical trials

The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

"This final rule will expedite FDA's review of critical safety information and help the agency monitor the safety of investigational drugs and biologics," said Rachel Behrman, M.D, associate director for medical policy in the FDA's Center for Drug Evaluation and Research. "These changes will better protect people who are enrolled in clinical trials."

The new rule requires that certain safety information that previously had not been required to be reported to FDA be reported within 15 days of becoming aware of an occurrence. These reports include:

findings from clinical or epidemiological studies that suggest a significant risk to study participants
serious suspected adverse reactions that occur at a rate higher than expected
serious adverse events from bioavailability studi