FDA
FDA approves drug for treating canine yeast ear infections
DuOtic by Dechra is the first otic drug intended to treat otitis externa that does not contain an antibiotic
New labeling regulations proposed by FDA for animal drugs
The Proposed Rule aims to improve content submission and format consistency
FDA provides funding opportunity for antimicrobial data collection
The cooperative agreements are a step toward the agency's efforts to support research with diverse animal sectors.
Man selling fraudulent canine cancer drugs sentenced to 97 months in prison
The defendant defrauded 900 pet owners out of almost $1 million
FDA allows temporary imports of unapproved cattle drug
The FDA not objecting to the importation is in response to a nationwide shortage of Folltropin
FDA drafts guidance on veterinary drug ingredients manufacturing
GFI #286 VICH GL60 is now seeking public comments
Voluntary recall issued for raw kitten and puppy food
Certain Blue Ridge Beef products may be contaminated with Salmonella and Listeria monocytogenes
FDA issues final guidance to assist sponsors of certain drugs for animals
The document describes the new animal drug approval process for minor uses and minor species and explains various scenarios that might arise
Top dvm360 articles of 2023: #11
We have compiled a countdown of our top 15 content in 2023, here is number 11
Top dvm360 articles of 2023: #15
We have compiled a countdown of our top 15 articles in 2023, here is number 15
FDA issues Priority Zoonotic Animal Drug draft guidance
The federal agency is is accepting public comments until February 16, 2024.
FDA issues warnings of unapproved antimicrobial animal drugs
Nine manufacturers and distributors received warning letters with concerns about federal law violations
FDA renews conditional approval of medication for chemotherapy-induced diarrhea
Canalevia-CA1 is the first treatment for this indication to receive the agency's support at this level
FDA determines drug for lifespan extension in large dogs to have a Reasonable Expectation of Effectiveness
Celine Halioua, founder and CEO of Loyal, discussed the potential of LOY-001, a developmental therapy, with dvm360.
FDA extends comment period for draft guidance on certain antimicrobial drugs
Feedback for draft GFI #273 can be submitted until January 5, 2024.
Zoetis officially launches 2 FDA approved drugs in the US veterinary market
Librela and Apoquel Chewable were approved earlier this year and are now available on the market
FDA reveals reauthorization of Animal Drug User Fee programs
The programs will be administered by the FDA until 2028
FDA’s new 5-year plan for antimicrobial stewardship in animals is released
The agency’s Center for Veterinary Medicine has set forth its goals for the 2024 to 2028 fiscal years
FDA releases Animal and Veterinary Innovation Agenda
The agenda is a step toward the FDA modernizing its approach to evaluating and supporting creating innovative animal and veterinary products.
FDA's draft guidance for informed consent with clinical studies is available
The agency is accepting public comments for 60 days from the date of publication in the Federal Register, starting September 15, 2023.
Therapy for canine idiopathic epilepsy receives FDA conditional approval
Fidoquel-CA1 is indicated to treat seizures associated with the condition
FDA issues warning over Salmonella contaminated pet food
Multiple lots of Darwin’s Natural Pet Products raw cat and dog food have tested positive for Salmonella
FDA approves first oral liquid medication to treat diabetes in cats
SENVELGO is a once daily medication to improve glycemic control in cats with diabetes mellitus
FDA requests public input on analyzing antimicrobial use in animals
The administration is looking for suggestion on best framework for collecting this data
Chewable tablet receives FDA approval for internal and external parasites in dogs
This approval is the latest addition of the NexGard portfolio
Federal court orders prescription animal drug supplier to pay more than $11M
Midwest Veterinary Supply was also sentenced to 1 year probation for distributing “misbranded” pharmaceuticals
Chewable tablet for controlling pruritus in dogs is approved by the FDA
Apoquel Chewable tablets from Zoetis are indicated to help manage itching and inflammation caused by allergic dermatitis and atopic dermatitis
FDA announces GFI #263 has transitioned to prescription status
Status change of certain medically important antimicrobial drugs for animals from over-the-counter to prescription
FDA and European Union expand Mutual Recognition Agreement to include animal drugs
The joint decision to expand the MRA's Sectoral Annex for Pharmaceutical Good Manufacturing Practices is a step toward strengthening use of each other’s animal drug inspection expertise and resources
Drug for acute onset of canine pancreatitis is launched on the US market
Conditionally approved by the FDA, fuzapladib sodium for injection is a leukocyte function-associated antigen-1 activation inhibitor.
