FDA Proposes Mandatory Electronic Report Submissions

The FDA announced today that it has proposed an amendment to its current regulations that would require all animal drug sponsors to submit certain adverse event and product manufacturing defect reports to the agency electronically.

The move to mandated electronic submissions is intended to improve the FDA’s systems for collecting and analyzing postmarketing safety reports by:

• Expediting the review of safety reports and identification of emerging issues
• Disseminating timely safety information to veterinarians and animal caretakers
• Allowing better standardized safety reporting among regulatory agencies
• Facilitating the international exchange of postmarketing safety information

“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,” the agency said in a press release announcing the proposal.

The proposed rule would officially replace the current system, which allows for either electronic or paper submissions. The FDA noted, however, that 99.7% of submitters already submit their reports electronically; the propsed rule is intended to make that figure 100%.

Under the new amendment, electronic submissions would be required for the following reports for approved new animal drugs:

• 3-day alert reports that applicants submit directly to FDA’s Center for Veterinary Medicine
• 15-day alert reports and follow-up reports
• Product/manufacturing defect and adverse drug experience reports

The FDA will begin accepting public comments on the amendment on February 14. Comments can be submitted electronically by visiting regulations.gov and typing docket number FDA-2017-N-6381 into the search box. Alternatively, comments can be mailed to the agency:

Dockets Management Staff

HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Docket number FDA-2017-N-6381 should be written on each page of written comments. Comments will be accepted through April 30, 2018.