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New clinical trial rules from FDA

The US FDA has issued new regulations increasing the amount of safety information that must be reported about investigational drugs

The US Food and Drug Administration (FDA) has issued new regulations increasing the amount of safety information that clinical trial sponsors must report to the federal agency about their investigational drugs and biologics.

Under the new final rule, sponsors of human trials must report to the FDA, within 15 days of becoming aware of them, findings from clinical or epidemiological studies that suggest a significant risk or serious, suspected adverse reactions that occur more frequently than expected.

In addition, the rule sets a 15-day deadline for reporting serious adverse events in bioavailability studies, which determine what percentage and at what rate a drug is absorbed into the bloodstream, and bioequivalence studies, which determine whether a generic drug has the same bioavailability as the brandname drug.

In some cases, the new rule will intentionally result in less rather than more information being presented to the FDA, as it clarifies situations in which it is appropriate to wait for more than one occurrence of a serious adverse event rather than reporting the first event.

"Under current regulations, drug sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event," the FDA explained. "Such reporting complicates and delays the FDA's ability to detect a safety signal… Reviewing and evaluating uninformative individual safety reports places a tremendous burden on the system without accompanying benefit."

Reflecting the increasing number of clinical trials conducted outside of the US, the rule also takes steps to make the FDA's reporting standards more consistent with 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.

"This should help lead to consistent, harmonised reporting for globally conducted clinical trials," the FDA said. "Safety information from clinical studies conducted outside the US can be evaluated along with information from US clinical trials."

29th September 2010

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