November 8, 2022
FDA Warns About Risk of Xylazine Exposure in Humans
The FDA is communicating to health care professionals about serious risks associated with xylazine exposure in humans. FDA is aware that xylazine is increasingly detected in the illicit drug supply and in drug overdoses. Xylazine is an FDA-approved animal drug used as a sedative and analgesic in veterinary medicine, but is not approved for use in humans. The FDA has issued an Alert and a letter to stakeholders to communicate the risks and considerations for management.
September 15, 2022
FDA Announces Delay in GFI #256 Enforcement
On September 9, 2022, FDA announced a six-month delay in enforcement for its GFI #256, Compounding Animal Drugs from Bulk Drug Substances. Routine inspectional activities were to begin on October 1, 2022. The delay was requested by the Alliance for Pharmacy Compounding, American College of Veterinary Pharmacists, American Pharmacists Association, National Community Pharmacists Association, and Society of Veterinary Hospital Pharmacists, among others, who say pharmacies need additional time to review the recommendations or make suggested changes to processes, and to submit nominations for bulk drug substances for compounding office stock.
Steven M. Solomon, DVM, MPH, Director, FDA’s Center for Veterinary Medicine, wrote in a letter, “Since publication of the final guidance on animal drug compounding FDA has engaged with a variety of stakeholders. We recognize that some pharmacies may need additional time to review the recommendations described in the guidance... Therefore, we are extending the ongoing outreach and education period that we previously announced. At this time, we do not intend to shift our resources toward routine inspectional activities until April 2023.”
August 22, 2022
VCA Animal Hospitals announced the launch of VCA Animal Hospitals Urgent Care, a new veterinary service offering that builds on VCA's existing network of hospitals. The first Urgent Care is now open in Los Angeles, with plans for future locations around the US in the months ahead. The hospitals will be urgent care only, and will offer free tele-triage.
April 14, 2022
FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances
On April 13, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk ingredients and the limited circumstances under which FDA will exercise enforcement discretion.
August 31, 2021
CVM Issues Safety Alert re: Ivermectin and COVID-19
CVM is concerned that people are using formulations of the drug ivermectin intended for animals, to treat or prevent COVID-19 in humans, and advises that people should not take products approved for veterinary use.
July 18, 2019
Recent Study: Increasing Expenditure on Pet Healthcare Services Drives the Companion Animal Specialty Drugs Market
Poor lifestyles and health issues for companion animals are some of the primary factors that are generating the demand for companion animal specialty drugs in the near future, according to a new report by Future Market Insights (FMI), entitled "Companion Animal Drug Market: Humanization of pets, market consolidation, and incremental innovation set to define the market landscape: Global Industry Analysis and Opportunity Assessment 2015-2025."
December 15, 2016
CVM Names New Center Director; Steven Solomon Assumes Directorship January 2017
The U.S. Food and Drug Administration today announced the selection of Steven M. Solomon, DVM, as the new leader of the agency’s Center for Veterinary Medicine (CVM). Dr. Solomon will assume the directorship in January 2017 from Tracey Forfa, J.D., who is currently serving as the Acting Director. Click here more information.
December 16, 2014
FDA Announces Pharmacy Compounding Advisory Committee Members
The US FDA announced the 14 members of the Pharmacy Compounding Advisory Committee responsible for providing advice on issues concerning drug compounding under the Federal FDCA. Click here for more information.
October 17, 2014
Draft GFI #227 on Two-Phased CMC Submissions Released
The U.S. Food and Drug Administration issued today draft Guidance for Industry #227: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections, with recommendations for ways animal drug sponsors can submit chemistry, manufacturing, and controls (CMC) data to the agency to improve the efficiency of the New Animal Drug Application (NADA) review process. Click here for more information.
July 31, 2014
FDA Announces FY 2015 Animal Drug User Fee Rates for ADUFA and AGDUFA
The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2015 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2013 (ADUFA III) and Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II).
AGDUFA, originally signed into law in 2008 and reauthorized in 2013, was designed to enhance the performance of the generic new animal drug review process and enable FDA to better ensure that generic new animal drug products are safe and effective, thus giving consumers a lower cost alternative to pioneer drugs. AGDUFA II reauthorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic new animal drug products, and from certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. The user fees for sponsors are pro-rated based on the number of approved abbreviated applications the sponsor currently holds. AGDUFA II reauthorizes FDA to collect user fees through FY 2018.
For more information, click here.
June 30, 2014
Full Industry Engagement on FDA's Antimicrobial Resistance Strategy
Generic Animal Drug Alliance worked alongside other industry groups to support the FDA's strategy to phase out antimicrobials, garnering support among generic animal drug sponsors. Click here for more information.