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Grant Dixon

Grant Dixon advises a range of international clients on pharmaceutical compliance and enforcement matters. In this area, Grant regularly counsels pharmaceutical manufacturers on U.S. CGMP compliance and remediating deficiencies identified during regulatory inspections, including preparation of submissions to regulators. He also conducts internal investigations of allegations concerning compliance with Current Good Manufacturing Practices, Current Good Clinical Practices, and other U.S. FDA regulatory requirements.

Grant also represents companies that manufacture feed, feed ingredients, drugs, biologics and medical devices for animals, those that provide veterinary medical services and that perform biomedical research, as well as clients in related industries.

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June 27, 2024, Covington Alert

On June 25, 2024, the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced that it has finalized Guidance for Industry (GFI) #276, Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs (Final Guidance). The Final Guidance replaces CVM’s draft guidance issued in November 2022. While CVM’s core recommendations remain the same, the Final Guidance clarifies the discussion and recommendations related to geographic locations from which Dirofilaria immitis (D. immitis) larvae used in trials should be sourced, laboratory dose confirmation studies, and field effectiveness studies for products intended to prevent heartworm disease. CVM’s stated overarching goal in making the revisions is to better align GFI #276 with current technology and veterinary epidemiology, including available diagnostic methodology. Drug sponsors who deviate from these recommendations are encouraged to discuss the deviations with CVM.

Background

On May 24, 2018, FDA published a Federal Register Notice requesting public input on possible alternative approaches for evaluating the effectiveness of heartworm disease prevention products for dogs. On its webpage announcing the final guidance, FDA explained that it asked for public input because of reports of lack of effectiveness and certain limitations of the effectiveness studies conducted to support product approval. FDA’s then-current recommendation for demonstrating the effectiveness of a new animal drug intended to prevent heartworm disease was for sponsors to conduct two laboratory dose confirmation studies and one multi-site field effectiveness study under the principles of Good Clinical Practice. FDA specifically requested input on the population level effectiveness endpoint, exposure to infective D. immitis larvae in field studies, outcome assessment in field studies, and laboratory study designs.Continue Reading FDA Issues Final Guidance on Demonstrating Effectiveness of Anthelmintics in Dogs

Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and

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Continue Reading FDA Releases Guidance on Resuming Normal Drug and Biologics Manufacturing Operations During COVID-19

On September 26, 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…
Continue Reading Expanded Conditional Approval Draft Guidance Issued