FDA revises rules on reporting safety information during clinical trials

The FDA on Tuesday issued a final rule clarifying how and when safety information must be reported during clinical trials of investigational drugs and biologics. Under the new rule, companies will be required to report to the FDA within 15 days after they become aware of certain safety occurrences, including data that suggest a significant risk to study participants and serious suspected adverse reactions that occur at higher-than-expected rates.

The revised rule also modifies the way in which drugmakers report serious adverse events by providing examples of when a single event should be reported and when it is best to wait for more than one occurrence. Currently, companies report all serious adverse events, even if the likelihood is low that the events are related to use of the experimental drug. "This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics," noted Rachel Behrman, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research, adding that "these changes will better protect people who are enrolled in clinical trials."

The new standards are designed to bring the agency's reporting standards in line with that of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences.

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