FDA Proposes to Require Electronic Submission of Certain Postmarketing Safety Reports for Approved New Animal Drugs
Updated July 28, 2020: The FDA has issued the final version of the rule, Postmarketing Safety Reports for Approved New Animal Drugs. The rule requires electronic submission of certain postmarketing safety reports for approved new animal drugs and provides a procedure for requesting a temporary waiver of the requirement. Based on limited public comments on the proposed rule that were generally supportive of FDA’s rulemaking and the agency’s ongoing efforts to improve systems for collecting and analyzing postmarketing safety reports, FDA determined no changes to the codified language that was included in the proposed rule were needed in the final rule.
February 13, 2018
The U.S Food and Drug Administration today proposed a rule 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. Receiving these postmarketing 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 the FDA carefully evaluates new animal drugs before approval, 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. If FDA scientists detect a potential safety concern, they develop a plan of action that could include requesting changes to the label and working with the drug sponsor to provide more information to veterinarians and animal owners about how to use the product more safely.
As of 2016, animal drug sponsors have voluntarily chosen to electronically submit approximately 99.7 percent of eligible postmarketing safety reports. The proposed rule would require electronic submission of the remaining 0.3 percent of postmarketing safety reports eligible for electronic submission. Temporary waivers from electronic submission requirements can be requested when electronic access is impacted, such as during natural disasters.
Ensuring that new animal drugs are safe and effective is a key agency mission. Electronic reporting of these postmarketing safety events allows the FDA to review, assess, and determine potential new issues earlier and faster than paper reporting, and also enables the agency to better harmonize safety reporting among regulatory agencies and facilitate the international exchange of postmarketing safety information.
The FDA is accepting public comments beginning on February 14. To electronically submit comments to the docket, visit www.regulations.gov and type docket number FDA-2017-N-6381 in the search box.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2017-N-6381 on each page of your written comments.
Comments will be accepted until April 30, 2018.
Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Additional Information
- Final Rule: Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
- Proposed Rule: Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
- Regulations.gov
Please note that the public comment period opens on February 14, 2018.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.