Print“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics, says Rachel Behrman, in the FDA’s Center for Drug Evaluation and Research.”
The U.S. Food and Drug Administration has finalized a rule clarifying what safety information must be reported during clinical trials of investigational drugs and biologics and when it should be reported.
“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” says Rachel Behrman, 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,” she says.
Any study findings that suggest a significant risk to study participants, unexpectedly common occurrences of suspected adverse reactions, or serious adverse events from bioavailability studies must now be reported to the agency within 15 days.
The agency is also hoping to help companies better understand which serious adverse events might be the cause of a safety problem linked to their investigational product. Drug sponsors frequently report all serious adverse events, even if there is little reason to believe the product caused the event, the agency said. Such high-volume reporting is complicating the agency’s “ability to detect a safety signal,” it says.
“The final rule lays out clear, internationally harmonized definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing reporting of meaningful, interpretable information,” the agency says.
October 07, 2010
http://www.burrillreport.com/article-getting_specific_on_safety.html
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