In order to minimize potential product liability associated with pharmaceutical products, companies regulated by the U.S. Food and Drug Administration should be vigilant in ensuring that adverse drug experiences, or “ADEs,” are reported to the FDA in a timely and complete manner. FDA regulations contain extensive requirements regarding the reporting of ADEs for companies involved in the distribution chain, such as manufacturers and distributors. Failure to report when required can result in an FDA enforcement action and exacerbate liability exposure.

A proactive ADE collection and reporting system will place a company in a better position to address unanticipated issues that may arise after full-scale commercial marketing has begun. Therefore, companies must know their regulatory responsibilities and implement procedures to ensure that ADEs are collected and reported, as required by law. This article covers only some of the requirements and issues to consider.

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