Health and Human Services Department Docket FDA-2017-N-6381 Proposed Rule

2018-02757: Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements

Comment Period Closed

Public comment closed .

Get alerted when the next rule lands

New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.

Alert me on new Health and Human Services Department rules or alert me on a subject

Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.

Create a free account & build one →

Summary

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted to FDA in an electronic format that we can process, review, and archive. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

Don't miss the comment window

One Click Politics alerts you on every deadline, hearing, and rule change.

See all rules with comments due soon →