Center for Veterinary Medicine

FDA Agrees Loyal Data Supports Reasonable Expectation of Effectiveness for Large Dog Lifespan Extension

Retrieved on: 
Tuesday, November 28, 2023

“Loyal was founded with the ambitious goal of developing the first drugs to extend healthy lifespan in dogs,” said Loyal CEO Celine Halioua.

Key Points: 
  • “Loyal was founded with the ambitious goal of developing the first drugs to extend healthy lifespan in dogs,” said Loyal CEO Celine Halioua.
  • It’s designed for drugs that demonstrate a reasonable expectation of effectiveness in addressing an unmet medical need, but require complex and difficult studies to complete collection of definitive effectiveness data.
  • It means the FDA agrees LOY-001 has a reasonable expectation of effectiveness and, once the FDA approves Loyal’s manufacturing and safety data packages, Loyal can market the drug for lifespan extension in the target canine population.
  • The Center for Veterinary Medicine at the FDA has reviewed Loyal’s data, results, and scientific arguments and determined they provide reasonable expectation of the drug’s effectiveness to extend canine lifespan and healthspan.

FDA Warns Nine Manufacturers, Distributors of Unapproved Antimicrobials for Animals

Retrieved on: 
Thursday, December 14, 2023

Antimicrobial resistance happens when microorganisms like bacteria become resistant to the antimicrobials that are designed to kill them.

Key Points: 
  • Antimicrobial resistance happens when microorganisms like bacteria become resistant to the antimicrobials that are designed to kill them.
  • Therefore, the FDA has not verified their safety or effectiveness as part of the animal drug review process or facility inspections.
  • Providing animals with the appropriate drug is more likely to effectively resolve infections and reduce the need for extended treatment with antimicrobials.
  • Self-diagnosis and treatment with unapproved animal antimicrobials could delay effective treatment, allowing infections to become more severe and/or more resistant to antimicrobials.

CULT Food Science Announces MOU for First of its Kind Supply Agreement for Cell-Cultivated Chicken

Retrieved on: 
Tuesday, August 22, 2023

In collaboration with Everything But, the Company will be including cell-cultivated chicken in its dog and cat foods brands, which currently include Noochies!

Key Points: 
  • In collaboration with Everything But, the Company will be including cell-cultivated chicken in its dog and cat foods brands, which currently include Noochies!
  • The regulatory pathway in pet food requires approval from the Center For Veterinary Medicine, a branch of the U.S. Food and Drug Administration.
  • The Company's cell-cultivated chicken products are expected to be among the world's first cell-cultivated chicken pet products brought to market.
  • The availability of the Company's cell-cultivated chicken pet products will be announced in the near future.

FDA Conditionally Approves First Drug for Anemia in Cats with Chronic Kidney Disease

Retrieved on: 
Monday, May 1, 2023

SILVER SPRING, Md. , May 1, 2023 /PRNewswire/ --Today, the U.S. Food and Drug Administration conditionally approved Varenzin-CA1 (molidustat oral suspension), the first drug for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats. Nonregenerative anemia can be a fatal condition because the cat's bone marrow is not able to produce enough red blood cells to replace the older or damaged red blood cells that are naturally removed from the blood, resulting in the inability for oxygen to be carried from the lungs throughout the body.

Key Points: 
  • , May 1, 2023 /PRNewswire/ --Today, the U.S. Food and Drug Administration conditionally approved Varenzin-CA1 (molidustat oral suspension), the first drug for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats.
  • CKD is a disease that requires day-to-day management in cats, and nonregenerative anemia is a complication that often contributes to death or euthanasia of affected cats due to poor quality of life.
  • Cats can develop CKD at any age, but it is frequently diagnosed in older cats.
  • The current treatments available for nonregenerative anemia in cats with CKD include blood transfusion, supplemental iron therapy and erythropoietin replacement.

FeedKind® Protein Wins FDA GRAS Status for Use in Aquaculture

Retrieved on: 
Monday, February 20, 2023

Calysta, the world leader in fermented protein, has announced that its leading product, FeedKind®, has achieved generally recognized as safe (GRAS) status with the United States Food and Drug Administration (FDA).

Key Points: 
  • Calysta, the world leader in fermented protein, has announced that its leading product, FeedKind®, has achieved generally recognized as safe (GRAS) status with the United States Food and Drug Administration (FDA).
  • The FDA’s Center for Veterinary Medicine have granted Calysta’s FeedKind protein GRAS status for use in the US in salmonid feeds at up to 18% of the diet.
  • Allan LeBlanc, VP and Aquaculture Lead at Calysta, said: “With so many exciting developments in US aquaculture, we are thrilled to be able to access this market.
  • FeedKind protein is a perfect fit for the trout industry and the burgeoning recirculating aquaculture systems (RAS) industry for Atlantic salmon.

University Products Alerts U.S. Cattle Ranchers: 'FDA Set to Change Status of Antimicrobial Drugs from Over the Counter to Prescription Soon, Forcing Many Ranchers to Use Expensive and Difficult-to-Obtain CTCs - So Prepare Now by Vaccinating Your Herd Aga

Retrieved on: 
Wednesday, January 18, 2023

The Center for Veterinary Medicine's (CVM) Guidance for Industry #263 goes into effect on June 12, 2023.

Key Points: 
  • The Center for Veterinary Medicine's (CVM) Guidance for Industry #263 goes into effect on June 12, 2023.
  • The guidance applies to all food animals and animals not intended for food, and includes penicillin, sulfa-based drugs, boluses, intramammary mastitis tubes, and topical products.
  • For decades, antimicrobials were used to treat seasonal diseases like anaplasmosis in cattle, but there are better options – like vaccines produced by University Products.
  • These requirements, temporarily put aside for the COVID-19 pandemic, can no longer "be met solely through telemedicine."

ZIVO Reports that USDA Claims Regulatory Jurisdiction for New Coccidiosis Treatment

Retrieved on: 
Wednesday, August 10, 2022

The global poultry industry spends more than $1.5 billion annually on coccidiosis control, primarily using decades-old compounds that face growing anticoccidial drug resistance.

Key Points: 
  • The global poultry industry spends more than $1.5 billion annually on coccidiosis control, primarily using decades-old compounds that face growing anticoccidial drug resistance.
  • Coccidiosis is a common disease for chickens, especially among young chicks, and can be fatal or result in compromised digestion.
  • Im delighted with todays announcement that demonstrates ZIVOs commitment to advancing our product candidate toward commercialization and provides regulatory clarity.
  • With regulatory jurisdiction now confirmed, we will advance discussions with the CVB on the final product development plan, regulatory strategy and data requirements for licensure.

Federal judge enters consent decree against New Jersey raw animal food manufacturer

Retrieved on: 
Monday, March 28, 2022

Today's action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation .

Key Points: 
  • Today's action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation .
  • Part 507 requires, among other things, that animal food facilities take adequate precautions to prevent animal food from becoming contaminated and that all animal food manufacturing, processing, packing, and holding is conducted under the conditions necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food.
  • During these inspections, the FDA found evidence of significant food safety violations including grossly insanitary conditions and the failure to follow CGMP regulations for animal food.
  • Multiple samples of finished raw pet food products collected during the inspections tested positive for Salmonella.

NIHC Sends Letters Proposing Webinar with Regulators on Animal Feed

Retrieved on: 
Thursday, March 17, 2022

Recently, a coalition of animal feed and nutrition groups and veterinarians led by AAFCO asked states to stop passing laws allowing hemp in animal feed without ample scientific research to support its use.

Key Points: 
  • Recently, a coalition of animal feed and nutrition groups and veterinarians led by AAFCO asked states to stop passing laws allowing hemp in animal feed without ample scientific research to support its use.
  • Additionally, FDA-CVM has requested that only studies using American grown and American processed hemp be included.
  • "It is incredibly disappointing that some choose to create confusion over feed ingredients versus animal supplements at the expense of American ranchers and farmers who need a safe, affordable and nutritious supply of animal feed that hempseed provides."
  • NIHC offered five clarifications and solutions for allowing hemp-based animal feed to gain federal approval.

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

Retrieved on: 
Monday, March 7, 2022

This is the FDA's first low-risk determination for enforcement discretion for an IGA in an animal for food use.

Key Points: 
  • This is the FDA's first low-risk determination for enforcement discretion for an IGA in an animal for food use.
  • "It also demonstrates our ability to identify low-risk IGAs that don't raise concerns about safety, when used for food production.
  • Although PRLR-SLICK cattle have an equivalent trait to those cattle with a naturally-occurring short hair coat, they are not currently in commerce.
  • Further, the food from the cattle is the same as food from conventionally bred cattle that have the same slick-hair trait.