Tuesday, May 14, 2024
FDA Clarifies Approach to Genomic Alterations in Animals
FDA, USDA Establish Memorandum of Understanding to Clarify Roles and Responsibilities for Regulation of Intentional Genomic Alterations in Animals
Today, the U.S. Food and Drug Administration took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. The updated guidance documents underscore the agency’s commitment to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, predictability and efficiency. In addition, the agency established a memorandum of understanding (MOU) with the U.S. Department of Agriculture (USDA) to clarify roles and responsibilities for regulation of IGAs in animals.
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- Today, the FDA announced that is has finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers, to provide guidance to industry on the requirements of the veterinary feed regulations (i.e., the Veterinary Feed Directive (VFD) final rule). The VFD final rule outlines the process for authorizing the use of approved animal drugs intended for use in or on the feed of food-producing animals that require veterinary oversight, including medically important antimicrobials when needed for specific animal health purposes. This final guidance also serves as a Small Entity Compliance Guide.
- On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs. Pimomedin (pimobendan) chewable tablets is approved for the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). Pimomedin is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. Pimomedin is only available by prescription from a licensed veterinarian.
On Wednesday, the FDA issued an additional warning letter that describes violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The warning letter issued to Cardinal Health (firm marketing and distributing plastic syringes made in China within the U.S.) also describes violations related to quality system regulations for syringe products. The FDA expects this firm to fully address the violations described in the warning letter. The FDA will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
FDA Announces Decision for a Tissue-based Product for use in Dogs
Today, the U.S. Food and Drug Administration announced it has made a risk-based decision based on its review of safety and quality data and information and does not expect the developer of PrecisePRP Canine (canine leucoreduced allogeneic pooled freeze-dried platelet-rich plasma) to submit an application for approval prior to marketing.
PrecisePRP Canine provides a species-specific source of concentrated platelets in plasma for injection directly into a dog’s joint (intra-articular injection). PrecisePRP Canine is the first animal cell, tissue, and cell- and tissue-based product (ACTP) intended for intra-articular use to undergo FDA review and receive this determination.
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FDA Finalizes Guidance to Provide Further Clarity on Veterinary Feed Directives
Today, the U.S. Food and Drug Administration finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers to assist stakeholders involved with veterinary feed directives (VFDs) – veterinarians, VFD feed distributors (medicated feed mills, feed retailers) and clients (owners or other caretakers of the animals) – in complying with the Veterinary Feed Directive (VFD) final rule that published in 2015. The VFD final rule outlines the process for authorizing the use of approved animal drugs in the feed of food-producing animals that require veterinary oversight, including medically important antimicrobials when needed for specific animal health purposes. This final guidance also serves as a Small Entity Compliance Guide.
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A Milestone in Facilitating the Development of Safe and Effective Biosimilars
The Biologics Price Competition and Innovation Act of 2009 created a pathway for the U.S. Food and Drug Administration to approve biosimilars. A biosimilar is a biological product (biologic) that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved biologic (also called the reference product). Biologics are some of the most expensive treatments in the U.S., and approving biosimilars can enhance competition, drive down costs to health care systems, and increase patient access to biologic therapies.
This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that treat a wide range of chronic and severe illnesses, and which have already had an important impact on patient access. Biosimilars are now approved for 15 different reference biologics, and treat illnesses like rheumatoid arthritis, inflammatory bowel disease, some cancers, psoriasis, diabetes, macular degeneration, osteoporosis, and more.
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