The Food & Drug Administration announced July 28 that it has issued the final version of the rule "Postmarketing Safety Reports for Approved New Animal Drugs," which requires electronic submission of certain post-marketing safety reports for approved new animal drugs and provides a procedure for requesting a temporary waiver of the requirement.

FDA said based on limited public comments on the proposed rule — which were generally supportive of FDA’s rule-making and the agency’s ongoing efforts to improve systems for collecting and analyzing post-marketing safety reports — the agency determined that no changes were needed to the codified language included in the proposed rule.

FDA proposed the rule Feb. 13, 2018, to require animal drug sponsors to submit to the agency certain adverse drug experience and product manufacturing defect reports on Form FDA 1932 in electronic format.

At the time, FDA said receiving these post-marketing safety reports electronically allows the agency to more rapidly review and identify emerging safety problems and notify veterinarians and animal caretakers about safety signals.

Although FDA carefully evaluates new animal drugs before approval, the agency noted that there is the potential for new information to emerge after marketing, when the product is used in a much larger population and in settings different from the controlled studies required by the approval process.

When the rule was proposed, FDA noted that as of 2016, animal drug sponsors had voluntarily chosen to electronically submit approximately 99.7% of eligible post-marketing safety reports.