fbpx
Sign up now!
Don't show this again

Thank you for confirming your subscription!

(And remember, if ever you want to change your email preferences or unsubscribe, just click on the links at the bottom of any email.)
Tap to download the app
X
Share
X

REPORTS

Collect articles and features into your own report to read later, print or share with others

Create a New Report

Favorites

Read Later

Create a new report

Report title (required) Brief description (optional)
CREATE
X
NEXT
POULTRY PORK
follow us


You must be logged in to edit your profile.

Favorites Read Later My Reports PHT Special Reports
Poultry Health Today is equipped with some amazing (and free) tools for organizing and sharing content, as well as creating your own magazines and special reports. To access them, please register today.
Sponsored by Zoetis

Sponsored By Zoetis

.

FDA Releases Biannual Progress Report on Judicious Use of Antimicrobials in Food-producing Animals

The number of new antimicrobial approvals was incorrectly reported when first published on February 26, 2015. The error was corrected on February 27, 2015.

February 26, 2015

The U.S. Food and Drug Administration announced today its second progress report on its strategy to promote the judicious use of antimicrobials in food-producing animals.

In December 2013, the agency took a significant step forward in addressing antimicrobial resistance by publishing Guidance #213, which calls on animal drug sponsors of approved medically important antimicrobials administered through medicated feed or water to remove from their product labels indications for use related to growth promotion, and bring the remaining therapeutic uses of these products under the oversight of a veterinarian by December 2016.

In March 2014, 283 applications were identified as being affected by Guidance #213. Since that time, 10 new generic and combination approvals were added to the list of affected applications; by law, the agency has no basis for refusing to approve these applications as long as they meet regulatory standards for approval. Some affected drug sponsors have already started implementing the recommended changes to their affected antimicrobial products: three applications have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application; and 32 affected applications have been completely withdrawn.

Sponsors of all of the affected applications, including the additions, remain committed to participating in the strategy. One drug sponsor who was not previously affected by GFI #213, Pharmgate LLC, acquired all of the affected applications of Pennfield Oil Co. and ADM Alliance Nutrition Inc. Pharmgate has notified the agency in writing of its intent to engage in the judicious use strategy as outlined in GFI #213.

The FDA continues to work closely with affected drug sponsors to help ensure that the changes they agreed to make as described in GFI #213 are completed in an orderly manner by the end of December 2016. The FDA also intends to use a variety of metrics to assess the effect of these changes over time, including existing data on drug sales and resistance as well as additional on-farm data. The agency is working closely with the U.S. Department of Agriculture and the Centers for Disease Control to hold a joint public meeting in the spring of 2015 to discuss ways to collect and use on-farm use data. Details of the public meeting will be released closer to the meeting date.




Posted on June 22, 2015

tags: , ,
RELATED NEWS



You must be logged in to edit your profile.

Google Translate is provided on this website as a reference tool. However, Poultry Health Today and its sponsor and affiliates do not guarantee in any way the accuracy of the translated content and are not responsible for any event resulting from the use of the translation provided by Google. By choosing a language other than English from the Google Translate menu, the user agrees to withhold all liability and/or damage that may occur to the user by depending on or using the translation by Google.