The US Food and Drug Administration announced the first in a series of 5 public meetings. The first will take place on July 17, 2024, and will provide attendees with educational sessions for those interested in the new animal drug approval process. The conferences will be hosted by the FDA and occur over the next 4 years as described in the “Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028.”

According to an organizational release, the Animal Drug User Fee Act (ADUFA) was signed into law in 2003 and was later subsequently reauthorized by Congress in in 2008, 2013, and 2023.

 The ADUFA authorizes the FDA to collect fees for certain new animal drug applications, establishments, products, and sponsors. Resources that are generated under ADUFA supplement the agency’s funding to improve the drug review process performance to better ensure new animal drug products are safe and effective for both animals and the food that is attained from treated animals, making it safe for consumption.

The most recent reauthorization of ADUFA, The Animal Drug User Fee Amendments of 2023 (ADUFA V), granted the FDA permission to collect user fees through fiscal year 2028 and “The Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028” sets the agency’s performance goals for the time period of ADUFA V.

 This document commits the agency to host triannual meetings with the Animal Health Institute and during the meetings, the FDA will be committing up to 8 hours for an educational conference intended for the animal drug industry, but open to the public.

The conference this year will give attendees a high-level overview of the approval process for animal drugs, communicate pathways with the FDA’s Center for Veterinary Medicine, best practices within the process, target animal safety technical section overview, environmental impact technical section overview, and more. There will also be Q&A sessions where the FDA will address specific questions from both virtual and in-person attendees. The release disclosed that future conferences will take a more in-depth approach to the topics as well as others based on attendee questions and comments received during this first meeting, and questions and comments submitted to the docket.

Stakeholders are encouraged to submit comments to the docket to request topics to be included for future conferences and the FDA will accept public comments at any time for these conferences. The FDA is only asking anyone submitting comments to do so written or electronic 90 days after each educational conference to make sure the agency considers your comment on a topic discussed at that conference.

The conference will be held in person at the FDA White Oak Campus located at 10903 New Hampshire Ave, Bldg 31, Great Room Conference Center, Silver Spring, MD 20993–0002 or virtually.

 Early registration is recommended by the FDA for anyone who plans to attend in person and those attending virtually can register until the start time of the meeting. In person attendees are encouraged to register no later than July 10, 2024 and on-site registration will be available on a first come first serve bases.

FDA announces first annual Animal Drug User Fee Educational Conference. News release. US Food and Drug Administration. June 17, 2024. Accessed June 17, 2024. 

https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-first-annual-animal-drug-user-fee-educational-conference?utm_medium=email&utm_source=govdelivery

VM public meeting: First Annual Animal Drug User Fee Educational Conference. News release. June 17, 2024. Accessed June 17, 2024. 

https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/cvm-public-meeting-first-annual-animal-drug-user-fee-educational-conference-07172024

Articles

The conference will be available to attendees in person or virtually

First animal drug user fee educational conference kicks off next month 

A new diagnostic test for multiple canine cancers is underway. Oxford BioDynamics (OBD), a biotechnology developer of precision medicine tests based on novel epigenetic biomarkers for pharmaceutical use, recently announced the development of the EpiSwitch Specific Canine Blood (SCB) test, a blood-based test that can diagnose 6 different canine cancers.

The EpiSwitch SCB test is based on OBD’s non-invasive array platform and uses a 3D genomic approach to diagnose multiple types of cancer, in addition to supporting continuing upgrade for additional diagnostic profiles in a modular manner. According to OBD, the test is aimed at helping veterinary professionals diagnose cancer, reduce unnecessary toxicity, make more informed treatment decisions, and optimize management of costs and resources.

“My first use of the EpiSwitch SCB test helped navigate a very complex case of canine cancer relapse in the absence of options from the current standards of care. This test opens possibilities for a quick and reliable diagnosis in the very cases where time is at premium,” Sara Fritz, DVM, said in a news release.

According to the release, the EpiSwitch SCB test will be offered to a limited number of veterinarians who will generate real-world utility data to further validate the test. Its commercialization is anticipated to occur through a partnership or licensing agreement with an organization already established in the pet healthcare sector.

The test can diagnose the following cancers in canines in a single array format that encompasses multiple classes and phenotypes of cancer

The EpiSwitch test, which was verified using comprehensive 3D whole-genome profiling from peripheral blood, showed high sensitivity and specificity for lymphomas and sarcomas as a class, with an accuracy level greater than 80%, and high sensitivity and specificity for specific individual indications, achieving accuracy greater than 89%.

“EpiSwitch SCB combines all the advantages of EpiSwitch blood-based biomarkers with a novel proprietary multi-choice EpiSwitch array design. Once again, we were determined to translate to practice the full potential of our EpiSwitch technology, this time to tackle a prevalent veterinary challenge in support of our four-legged friends,” said Alexandre Akoulitchev, chief scientific officer at OBD.

Cancer is the leading cause of death for dogs who are in their senior years.

 Moreover, it is estimated that 1 in 4 dogs will develop cancer at some point in their lives,

 with the 5 most common types of cancer in canines being mast cell tumors, melanoma, lymphoma, osteosarcoma, and hemangiosarcoma.

 According to the National Canine Cancer Foundation, certain dogs breeds are more predisposed to cancer. Some of those breeds include Golden Retrievers, Boxers, Bernese Mountain dogs, German Shepherds and Rottweilers. In larger dogs, such as Irish Wolfhounds, Great Danes, and Scottish Deerhounds, osteosarcoma is more prevalent. Meanwhile, malignant melanoma has a higher likelihood of appearing in black canines, typically in their toes or toenail bed.

According to OBD, current alternative non-invasive methods in canine cancer detection are not able to differentiate between different types of cancers. Additionally, they only provide a binary ‘cancer’ or ‘no cancer’ result. “The ability to detect the presence of common, life-threatening dog cancers with high accuracy using blood samples provides an improvement over current methods of diagnosis, reducing or eliminating the need for invasive biopsy procedures. I believe that the eventual implementation of these tests also has potential to enhance the precision and therefore improve the management and outcomes of canine cancer patients,” expressed Jaime Modiano, VMD, PhD, professor at the College of Veterinary Medicine and Masonic Cancer Center at the University of Minnesota.

Oxford BioDynamics develops a high accuracy, discriminating diagnostic test for multiple canine cancers. News release. Oxford BioDynamics Plc. June 4, 2024. Accessed June 17, 2024. 

https://www.businesswire.com/news/home/20240604452146/en/Oxford-BioDynamics-Develops-a-High-Accuracy-Discriminating-Diagnostic-Test-for-Multiple-Canine-Cancers

Hunter E, Salter M, Powell R, et al. Whole genome 3D blood biopsy profiling of canine cancers: Development and validation of EpiSwitch Multi-Choice array-based diagnostic test. 

https://doi.org/10.1101/2024.05.22.595358

Coppock K. Advances in cancer screening and detection. 

https://www.dvm360.com/view/advances-in-cancer-screening

Evelyn K. Which dog breeds are prone to cancer? Why? The National Canine Cancer Foundation. January 20, 2021. Accessed June 17, 2024. 

https://wearethecure.org/blog/dog-breeds-prone-to-cancer/#:~:text=Sadly%2C%20it%20is%20estimated%20that,modern%20chemotherapies%20to%20treat%20dogs

The EpiSwitch Specific Canine Blood test can detect up to 6 types of cancer in canines in a single array format

New diagnostic test can detect multiple types of cancer in dogs

Non-steroidal anti-inflammatory drugs (NSAIDs) are the most used medication for cats.

 However, felines have a unique metabolism that should be considered when prescribing NSAIDs.

 Moreover, careful adherence to dosage regimens and knowledge of contraindications for NSAID use are crucial for maintaining the health safety of cats.

 To assist veterinary professionals in making informed decisions regarding the prescription of NSAIDs in cats, specific to its long-term use to manage chronic pain, the International Society of Feline Medicine (ISFM) and the American Association of Feline Practitioners (AAFP) developed the “2024 ISFM and AAFP consensus guidelines on the long-term use of NSAIDs in cats.”

“We are thrilled to announce the release of these new guidelines addressing long-term use of NSAIDs in cats,” said Heather O’Steen, CEO of AAFP in a news release.

 “With a focus on safety, efficacy, and responsible medication management, these guidelines aim to enhance the quality of life for cats while minimizing potential risks. We believe that these guidelines will serve as a vital resource in ensuring the optimal care and wellbeing of cats receiving long-term NSAID therapy.”

The guidelines offer comprehensive information including research, figures, and charts on the following in relation to the long-term use of NSAIDs in felines

Avoidance and management of adverse effects

Considerations for anesthesia and surgery in cats receiving long-term NSAID therapy

Cat-friendly techniques to reduce chronic pain in the clinic and at home

“The first NSAID guidelines were published in 2010. Since then, multiple studies have examined the use of NSAIDs in cats, particularly those with comorbidities. These guidelines have examined this evidence and aim to provide practitioners with practical information on using NSAIDs for chronic pain management, along with tips and advice on working with caregivers to provide the best care for their cat,” Sam Taylor, BVetMed(Hons), CertSAM, DipECVIM-CA, MANZCVS, FRCVS, head of veterinary specialists at ISFM, and contributing author, explained in the news release.

The 26-page guidelines also included information on contraindications to the use of NSAIDs. Contraindications were divided into “absolute contraindications” and cases where “caution [is] required.”

 According to the guidelines, absolute contraindications include the following

Concurrent treatment with drugs that affect renal function (eg, aminoglycosides)

Liver dysfunction/failure (eg, hepatic lipidosis)

Anorexia, vomiting, melena, and/or diarrhea

Acute gastrointestinal disease, gastrointestinal disease with compromised mucosa

Cases where caution is required before administering NSAIDs include

Advanced age, such as ‘super’-senior cats aged more than 15 years

Other gastrointestinal disease without mucosal compromise

Concurrent treatment with other drugs, such as ACE inhibitors/angiotensin receptor blockers, diuretics, anticoagulants; and highly protein-bound drugs such as warfarin, digoxin and anticonvulsants

Furthermore, the authors emphasized the harm of administering human NSAID drugs to felines. “Human NSAID products given to cats are likely to cause severe toxicity,” the authors wrote. “Any NSAID can induce significant adverse effects when dosage regimens are not followed or contraindications for use exist… The risk of NSAID-induced adverse effects is minimized by judicious selection of patients, consideration of concurrent medications, frequent monitoring, accurate drug administration and caregiver education,” they added.

Resources to provide feline caregivers with

In congruence with the guidelines’ section on cat-friendly advice and suggestions to support caregivers, the ISFM created “cat carer guides”

 that cover a wide range of topics such as how to increase water intake, care for a new kitten, recognize acute pain, and taking feline companions to veterinary visits. The AAFP also offers a 

 on managing chronic pain in cats taking NSAIDs.

Mallat J. The 9 most common cat medications. Catster. April 13, 2024. Accessed June 14, 2024. 

https://www.catster.com/cat-health-care/common-cat-medications/

Taylor S, Gruen M, KuKanich K, et al. 2024 ISFM and AAFP consensus guidelines on the long-term use of NSAIDs in cats. 

https://journals.sagepub.com/doi/epdf/10.1177/1098612X241241951

ISFM and the AAFP release new guidelines on the long-term use of NSAIDs in cats. News release. International Cat Care. April 10, 2024. Accessed June 14, 2024. 

https://icatcare.org/isfm-and-the-aafp-release-new-guidelines-on-the-long-term-use-of-nsaids-in-cats/

Cat carer guides. International Cat Care. Accessed June 14, 2024. 

https://icatcare.org/advice-cat-carer-guides/

ISFM, AAFP update guidelines on long-term NSAID use in cats. American Veterinary Medical Association. June 13, 2024. Accessed June 14, 2024. 

https://www.avma.org/news/isfm-aafp-update-guidelines-long-term-nsaid-use-cats?utm_source=delivra&utm_medium=email&utm_campaign=todays-headlines-news

The International Society of Feline Medicine and the American Association of Feline Practitioners updated the guidelines on the long-term use of NSAIDs in felines

Guidelines for the use of NSAIDs to treat chronic pain in cats 

Good morning and happy Monday dvm360 readers! Did you know that dvm360 has a Wag Shop? This month, we are offering 15% in celebration of pride month! Be sure to check it out to get yourself some Pride merchandise, regular Fetch merchandise, posters for your clinic like the ones you see at Fetch conferences, and maybe even something for your pet! You can find the Wag Shop 

As you wait for your Wag Shop order, here is what you can find this week on dvm360.com:

FDA announced that on July 17, 2024, it will host the first of a series of 5 public educational meetings to help stakeholders get a better understanding of the new animal drug approval process

VCA shared the news that it has rebuilt a hospital in Florida that was destroyed by Hurricane Ian in 2022, with enhanced canine and feline services for supporters, plus the publishing of the 2024 Hurricane Preparedness Playbook for clients.

On this week’s episode of The Vet Blast Podcast, Alex Sigmund, DVM, DACVO, joins host Adam Christman, DVM, MBA, to discuss everything veterinary professionals need to know about glaucoma.

Vetsource, a pet pharmacy and technology services company, disclosed that it will being shipping out of its new pharmacy location in Northlake, Texas last week. The latest addition is the third pharmacy Vetsource has opened, following one in Portland, Oregon, and one in Harrisburg, Pennsylvania.

The AVMA House of Delegates is scheduled to vote on accepting an updated version of policies for humane transportation of livestock and the Principles of Veterinary Medical Ethics during its annual session on June 20-21, in Austin, Texas.

Here is a sneak peek at this week’s headlines 

Sneak peek: FDA launches animal drug user fee educational conference, and other veterinary news 

Boxie, a pet products company, has launched the new “Glo” litter box formula that is designed with patent-pending UV crystals to guide cats to their litter box. Boxie is hoping this new technology will help prevent litter box aversion in cats.

Glo litter box formula. (Photo courtesy of Boxie)

Founder and CEO of Boxie, Josh Wiesenfeld stated in a news release, "Every year, millions of beloved cats are surrendered to shelters due to litter box aversion. This heartbreaking reality sparked the idea for Glo – a litter solution engineered to guide cats to their litter box and mitigate common behavioral issues."

Boxie stated that recent studies showing that cats can perceive UV light

 prompted the company to explore this avenue of technology research. According to the release, the Glo design also prioritized paw feel and scent attractants to further entice cats to use the litter box.

"Many existing litters are reactive, focusing on monitoring cat health after the fact or addressing issues post-use. Glo aims to change that narrative by proactively supporting cat health before problems arise. From FLUTD to asthma and inappropriate elimination, our products are designed to prevent these issues at their source,” said Wiesenfeld.

Boxie conducted initial rounds of testing and feedback of Glo to gauge the reaction from cats and their owners. According to the company, the product has seen positive reactions and owners claim to notice significant improvements in litter box usage. Wiesenfeld said, "We've received numerous testimonials from owners whose cats, previously prone to eliminating on soft surfaces, are now consistently using the litter box. At Boxie, we prioritize the well-being of cats, humans, and homes alike – achieving litter box success is a win for everyone involved."

Boxie recognizes that one of the main challenges of Glo and its UV technology, is that the UV crystals are invisible to the human eye, making it difficult to show the innovation to owners. Wiesenfeld hopes that the increased inclination of cats to use the litter box will provide a compelling incentive for owners to choose Glo.

Introducing Glo: Boxie's revolutionary cat litter that uses patent-pending UV technology to help guide cats to the litter box. News release. Boxie. June 11, 2024. Accessed June 17, 2024. 

https://prnmedia.prnewswire.com/news-releases/introducing-glo-boxies-revolutionary-cat-litter-that-uses-patent-pending-uv-technology-to-help-guide-cats-to-the-litter-box-302170019.html

Travouillon KJ, Cooper C, Bouzin JT, Umbrello LS, Lewis SW. All-a-glow: spectral characteristics confirm widespread fluorescence for mammals. 

A new product in the pet industry helps guide cats to the litter box

UV technology-enhanced litter box

Short-term manual soaking postprocedure breaks down soils and prevents them from drying on instruments

In the hustle and bustle of a veterinary clinic, time is a precious commodity. Every minute counts, especially when it comes to keeping high infection control standards, while managing multiple procedures simultaneously. However, instruments require immediate cleaning after use, and the drying of soils on these instruments can lead to unnecessary complications. So, how can veterinary clinics effectively combat this issue and streamline their cleaning processes?

Picture this: a busy day at the clinic with back-to-back procedures. The instruments used in these procedures pile up, waiting to be cleaned. Unfortunately, soil on these instruments can dry within minutes, making cleaning a more laborious and time-consuming task. Vigorous scrubbing becomes necessary, leading to potential corrosion of instruments and increased cleaning time.

Thankfully, there are proactive measures clinics can take to prevent the drying of soils on instruments, thereby saving time and ensuring efficient cleaning processes. Here are some strategies to consider:

 Immediate manual soaking of instruments post-procedure is crucial. Enzymatic detergents are effective in breaking down soils and keeping instruments wet, thus preventing drying. However, it's essential to limit soak time to no more than 30 minutes to avoid corrosion issues.

In scenarios where the time between procedure and cleaning exceeds 30 minutes, pretreatment of instruments with enzymatic sprays or sponges is highly beneficial. These products break down soils and start the cleaning process, while protecting instruments during extended delays.

For endoscopes, specialized pretreatment cleaning sponges are invaluable. These sponges, saturated with quadruple enzymatic detergent, are designed to clean the outer surface of endoscopes and flush the inside, ensuring thorough cleaning and maintenance of these delicate instruments.

Specialized pretreatment cleaning sponges clean the outer surface of endoscopes and flush the inside

Efficiency is paramount in any veterinary clinic. By implementing proper cleaning processes and using veterinary-approved cleaning chemicals, clinics can ensure that instrument cleaning never becomes a bottleneck in their operations.

With the right strategies in place, clinics can save time, increase productivity, and support best infection control standards, ultimately enhancing the quality of care provided to their animal patients. With the right knowledge and tools, veterinary clinics can take control of their time and navigate through busy workdays with ease, all while prioritizing the health and safety of their patients.

 is account manager for MicroCare Medical, which specializes in cleaning and infection control fluids for the veterinary industry.

These tips can save time and ensure instrument hygiene