January 14, 2021
Today, the U.S. Food and Drug Administration granted the first conditional approval under its expanded authority to KBroVet-CA1 (potassium bromide chewable tablets) to control seizures in dogs with idiopathic epilepsy. Idiopathic epilepsy is a type of seizure disorder without a known cause. KBroVet-CA1 works by stabilizing neurons in the central nervous system to reduce the likelihood of having a seizure.
Congress granted the FDA a limited expansion of the conditional approval pathway for certain new animal drugs under the 2018 reauthorization of the FDA’s Animal Drug User Fee Act (ADUFA) program. Conditional approval allows an animal drug sponsor to legally market its product after demonstrating that the drug is safe and manufactured in accordance with full approval standards, and that there is a reasonable expectation of effectiveness for use.
The aging Plum Island facility (dating from 1954) operates “biosafety level three” laboratories, which refers to safety standards set by the Centers for Disease Control and Prevention. On the other hand, the NBAF will have laboratories at biosafety level 4, the highest level, which allows for expanded research of significantly more virulent diseases.
The Department of Homeland Security (DHS), which is responsible for security at the labs, states that the NBAF will cover the full gamut of diseases, researching “high-consequence biological threats involving human, zoonotic (i.e., transmitted from animals to humans) and foreign animal diseases.”
In 2010, the Government Accountability Office tasked a committee to assess DHS safety and security plans. The results were not encouraging.
Wisconsin Ag News Headlines
Wisconsin Ag Connection - 12/29/2020 The Wisconsin Veterinary Examining Board has launched the Veterinary Professional Assistance Program and Work-Life Services, a confidential program designed to help licensed veterinarians and certified veterinary technicians manage the physical and mental
challenges associated with the profession.
The VPAP is a professional assistance and wellness program for veterinarians and veterinary technicians. It offers guidance and assistance with family issues, finding child and adult care, workplace concerns, legal and financial issues, stress, health and wellness,
and other issues. Examples of wellness issues include chemical dependence, psychiatric illness, professional burnout, and compassion fatigue.
Meanwhile, the VEB assumes all costs for the program, which was launched in partnership with Humana. VPAP services are confidential and available to veterinary professionals and their household members 24 hours a
Uses third-party lab testing
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