On July 10, 2019, the U.S. Food and Drug Administration’s Center for Veterinary Medicine issued a final rule, “New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.” This final rule standardizes and clarifies the standards for determining, codifying, and updating tolerances, and also provides a definition section of key terms that the FDA uses in the determination of tolerances. This final rule will enhance understanding of tolerance determination and improve the overall readability of the relevant regulations. The rule does not establish new tolerances. The FDA first proposed the rule in 2012 and requested public comment. The agency issued a supplemental proposed rule for a second public comment period in 2016, and the FDA took these comments into consideration while developing the final rule. The final rule will become effective 60 days from the date of publication in the Federal Register. [Source: FDA 10 July 2019]
Category Archives: FDA
FDA Issues Revised Question & Answer Draft Guidance on Veterinary Feed Directive Regulation
The U.S. Food and Drug Administration issued draft revised guidance for industry (GFI) #120, “Veterinary Feed Directive Regulation Questions and Answers.” The guidance aids industry in complying with the requirements of the Veterinary Feed Directive (VFD) final rule published in June 2015, and serves as a Small Entity Compliance Guide. [Source: FDA 27 March 2019]
FDA Issues Revised Question & Answer Draft Guidance on Veterinary Feed Directive Regulation
The U.S. Food and Drug Administration issued draft revised guidance for industry (GFI) #120, “Veterinary Feed Directive Regulation Questions and Answers.” The guidance aids industry in complying with the requirements of the Veterinary Feed Directive (VFD) final rule published in June 2015, and serves as a Small Entity Compliance Guide. [Source: FDA 27 March 2019]
FDA Announces Public Meeting to Discuss Foods Produced Using Animal Cell Culture Technology
The U.S. Food and Drug Administration announced today a public meeting to discuss foods produced using animal cell culture technology. The public meeting will be held on July 12, 2018 from 8:30 a.m. until 3:00 p.m. at the Harvey W. Wiley Federal Building, 5001 Campus Drive, Auditorium (first floor), College Park, MD 20740. [Source: FDA.gov, June 15, 2018]
FDA Announces Public Meeting to Discuss Foods Produced Using Animal Cell Culture Technology
The U.S. Food and Drug Administration announced today a public meeting to discuss foods produced using animal cell culture technology. The public meeting will be held on July 12, 2018 from 8:30 a.m. until 3:00 p.m. at the Harvey W. Wiley Federal Building, 5001 Campus Drive, Auditorium (first floor), College Park, MD 20740. [Source: FDA.gov, June 15, 2018]
FDA Announces Public Meeting to Discuss Foods Produced Using Animal Cell Culture Technology
The U.S. Food and Drug Administration announced today a public meeting to discuss foods produced using animal cell culture technology. The public meeting will be held on July 12, 2018 from 8:30 a.m. until 3:00 p.m. at the Harvey W. Wiley Federal Building, 5001 Campus Drive, Auditorium (first floor), College Park, MD 20740. [Source: FDA.gov, June 15, 2018]
FDA Issues Guidance on the Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species # 210
The U.S. Food and Drug Administration has issued final guidance for industry, “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” This final guidance includes only minor editorial differences from the draft guidance to improve clarity. [Source: FDA, April 26, 2018]
FDA Proposes Biomass Method to Obtain Animal Antimicrobial Sales and Distribution Data based on Animal Species and Weight
The U.S. Food and Drug Administration is publishing a paper proposing the use of a biomass denominator to adjust annual data on the amount of antimicrobials sold or distributed for use in food-producing animals in the United States. This adjusted estimate will provide insight into broad shifts in the amount of antimicrobials sold for use in food-producing animals and give the agency a more nuanced view of why sales increase or decrease over time in a manner that is specific to U.S. animal production. Such analysis will also support our ongoing efforts to encourage the judicious use of antimicrobials in food-producing animals to help ensure the continued availability of safe and effective antimicrobials for animals and humans. [Source: FDA, CVM, August 14, 2017]
FDA Ban on Powdered Medical Gloves Applies to Veterinary Use
On December 19, 2016, the Center for Devices and Radiological Health at the U.S. Food and Drug Administration issued a final rule banning all powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves intended for use by humans because these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by a change in labeling. The FDA’s Center for Veterinary Medicine is issuing this update to ensure that veterinary stakeholders are aware that the ban applies to all powdered medical gloves used by humans except powdered radiographic protection gloves, including powdered medical gloves used in the practice of veterinary medicine. [Source: FDA CVM, 1/13/2017]
Is It Really ‘FDA Approved?’
“FDA approved!”Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say their products are “FDA approved,” but how can you know for sure what the U.S. Food and Drug Administration approves?