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- FDA Releases Draft Guidance Regarding Current Good Manufacturing Practice Requirements for Animal
FDA Releases Draft Guidance Regarding Current Good Manufacturing Practice Requirements for Animal Food
August 26, 2016, Covington Alert
Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry #235, “Current Good Manufacturing Practice Requirements for Food for Animals,” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance contains information designed to help animal food facilities determine whether they need to comply with the animal food current good manufacturing practice (CGMP) requirements in 21 C.F.R. part 507 and, if so, how. Unlike the draft guidance FDA also issued this week on CGMP requirements for human food, this animal food CGMP guidance is not intended to be part of a multi-chapter guidance, but is a stand-alone document. There will, however, be future guidances on other provisions of part 507, including hazard analysis and preventive controls for animal food. This alert highlights key aspects of the draft guidance that will be of interest to industry stakeholders.
January 13, 2020
WASHINGTON—Covington represented Elanco Animal Health in connection with an agreement with Dechra Pharmaceuticals to divest Osurnia® for $135 million in an all-cash deal. Covington also represented Elanco in an agreement to divest the U.S. rights and related assets for Capstar® to PetIQ, Inc., for $95 million in an all-cash deal. Elanco is a global animal ...
Six Covington Lawyers Named Law360 MVPs
January 3, 2017
WASHINGTON—Law360 has named six Covington lawyers as MVPs in their respective practice areas. The awards single out lawyers from across various practice areas based on their “success in high-stakes litigation, complex global matters, and record-breaking deals.” The Covington lawyers recognized as Law360 MVPs are: Shara Aranoff, International Trade. Ms. ...
Food & Beverage MVP: Covington's Jessica O'Connell
December 20, 2016, Law360
Law360 selected Jessica O’Connell as a 2016 Food & Beverage MVP and profiled her involvement in FDA’s decision to review its “healthy” labeling regulations after convincing the agency to refrain from taking legal action against Kind LLC over allegedly misleading labeling of snack bars. According to O’Connell, her intimate understanding of the FDA was helpful as ...