FDA issues rule on safety information during clinical trials
Brings it into line with other international organisations
The US Food and Drug Administration (FDA) has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics, bringing it in line with standards from other international organisations.
The new rule requires companies to report to the FDA within 15 days of becoming aware of certain safety occurrences, including study findings ‘that suggest a significant risk to study participants’ and higher-than-expected adverse reactions to the treatment.
The rule also modifies the way drug companies report serious adverse events by clarifying whether such events should be reported after just one event or after more than one occurrence.
Rachel Behrman, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research, said the new rule ‘will expedite the FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics’.
It will also better protect people who are enrolled in clinical trials, she said.
The rule also revises definitions and reporting standards so that they are more consistent with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organisation’s Council for International Organisations of Medical Sciences.
The changes are designed to help ensure harmonised reporting of globally conducted clinical trials, the FDA said.