Our Website Uses Cookies
We and the third parties that provide content, functionality, or business services on our website may use cookies to collect information about your browsing activities in order to provide you with more relevant content and promotional materials, on and off the website, and help us understand your interests and improve the website.
For more information, please contact us or consult our Privacy Notice.
Your binder contains too many pages, the maximum is 40.
We are unable to add this page to your binder, please try again later.
This page has been added to your binder.
- Home
- News and Insights
- Insights
- New Draft Guidance on Veterinary Drug Compounding from Bulk Drug Substances
New Draft Guidance on Veterinary Drug Compounding from Bulk Drug Substances
November 27, 2019, Covington Alert
Last week, the United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) published Draft Guidance for Industry No. 256, “Compounding Animal Drugs from Bulk Drug Substances” (Draft Guidance).
October 7, 2019, Covington Alert
FDA has been active on the FSMA front, and released two new documents over the last few days. Last Friday, October 4, the Agency issued a draft guidance regarding establishing and implementing a recall plan under 21 CFR 117.139, the provision of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PC Human ...
September 27, 2019, Covington Alert
Yesterday, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) issued a draft guidance explaining the criteria it plans to apply when granting “expanded conditional approval” to new animal drugs not intended for minor uses or minor species that address a serious or life-threatening disease or condition or fill an unmet animal or ...
August 18, 2016, Covington Alert
Nineteen years after first publishing its proposal, FDA published in yesterday’s Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in human and animal food. This Alert addresses the final rule as it applies to food for animals. For an analysis of how the final rule will affect human food, see our Alert “FDA ...