ARTICLE
23 November 2016

FDA Proposes To Update Tolerances For Residues Of New Animal Drugs In Food

JD
Jones Day

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
FDA is reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.
United States Food, Drugs, Healthcare, Life Sciences

In the October 28, 2016, Federal Register, FDA proposed to amend its 2012 document titled "New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food." The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. FDA also proposed to add definitions for key terms. In this document, FDA is proposing to revise or remove some of the previously proposed definitions (e.g., removing the definition for "regulatory method"), taking into account comments the Agency received, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. FDA is reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule. Comments are due December 27, 2016.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

See More Popular Content From

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More