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FDA Releases Two New FSMA-Related Documents
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 Last Friday, October 4, the Agency issued a draft guidance regarding establishing and implementing a recall plan under 21 CFR 117.139, the provision of the Current Good Manufacturing Practice, Hazard Analysis, and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 Food) rule that requires facilities to establish a written recall plan for food that requires a preventive control.
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Yesterday, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) issued a draft guidance explaining the criteria it plans to apply when granting “expanded conditional approval” to new animal drugs not intended for minor uses or minor species that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 ...
January 23, 2017, Covington Alert
On Friday, President Trump (through his Chief of Staff) issued a memorandum directing all federal agencies to place a freeze on new or pending federal regulations so that the Trump Administration can review them. This alert explains the scope of this action and analyzes its potential impact on key food regulatory initiatives.
January 5, 2017, Covington Alert
Yesterday, FDA issued a long-anticipated draft guidance intended to help industry comply with the agency’s May 2016 final rules modernizing nutrition labeling. Presented in a question-and-answer format, the draft guidance (Q&A Draft Guidance) provides information related to the compliance date, labeling of added sugars, rounding of the declaration of ...