Clinical Trials: FDA publishes final Rules for Safety Reporting

The US Food and Drug Administration (FDA) has issued final regulations for Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans. This final rule addresses the safety reporting requirements which are defined in 21 CFR Part 312 and Part 320. The aim is to improve the quality of safety reports submitted to the FDA by laying out clear definitions and standards which are harmonised with those of ICH and WHO.

"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."

It is important to notice that new certain safety information must be reported to the agency within 15 days:

  • 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 studies which determine what percentage and at what rate drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug

This information had previously not been required to be reported.

Also, examples are given that would suggest that an investigational product may be the cause of a safety problem. These examples should give guidance when a single event should be reported or when there is need to wait for more than one occurrence. The reason is that currently sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event.

Along with the final rule the FDA also issued a draft guidance for industry and investigators that provides information and advice about the new requirements and other information and Q&As on the final rule.

Compiled by Wolfgang Schmitt
On the behalf of the European Compliance Academy (ECA )

Source: FDA Press Release

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