Today the U.S. Food and Drug Administration is proposing new regulations to provide animal drug sponsors with predictable requirements for the labeling of prescription and over-the-counter new animal drugs, as well as new animal drugs for use in animal feeds. The proposed content and format of labeling would also benefit veterinarians, animal owners, and animal producers by providing a more consistent presentation of information on the safe and effective use of these new animal drugs.
Category Archives: FDA
Comment Now: FDA Proposes New Regulations for Animal Drug Labeling
Today the U.S. Food and Drug Administration is proposing new regulations to provide animal drug sponsors with predictable requirements for the labeling of prescription and over-the-counter new animal drugs, as well as new animal drugs for use in animal feeds. The proposed content and format of labeling would also benefit veterinarians, animal owners, and animal producers by providing a more consistent presentation of information on the safe and effective use of these new animal drugs.
For Comment: FDA Releases Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
Open for Public Comment: FDA Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
For Comment: FDA Releases Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
Open for Public Comment: FDA Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
FDA Releases Plan for Supporting Antimicrobial Stewardship in Veterinary Settings for FY 2024-2028
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) released, “Supporting Antimicrobial Stewardship in Veterinary Settings, Goals for Fiscal Years 2024-2028.” This five-year plan builds upon the progress of the previous plan for FY 2019-2023.
FDA Supports Innovation in Animal Biotechnology, Veterinary Products, Food for Animals Through New Comprehensive Agenda
The U.S. Food and Drug Administration announced it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase regulatory flexibility, predictability and efficiency.
Preparing for Prescription-Only Antibiotics in Livestock Industry: Important Changes Ahead
While another month has come and gone for the 2023 production year, if you haven’t already heard, June will hold some significant changes for the livestock industry. On June 11, the FDA’s Guidance for Industry (GFI) #263 will take effect, bringing 91 over-the-counter antimicrobial products under prescription oversight.
FDA Announces Animal Biotechnology Webinar on Low-Risk Intentional Genomic Alterations in Animals for Food Use
Today the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is announcing new resources for people interested in the development of intentional genomic alterations (IGAs) in animals. These include a pre-recorded, on-demand webinar about the agency’s risk-based review process for IGAs in animals that may pose low risk, as well as revamped web resources for biotechnology products at CVM.
FDA Releases Draft Guidance on Bringing Remaining Approved Over-The-Counter Medically Important Antimicrobial Drugs Used for Animals Under Veterinary Oversight
Today, the U.S. Food and Drug Administration released draft guidance for industry (GFI) #263 to explain the recommended process for voluntarily bringing remaining approved animal drugs containing antimicrobials of human medical importance (i.e., medically important) under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter (OTC) to prescription (Rx). [Source: FDA 23 Sept 2019]
FDA Publishes Assessment of Compliance with Veterinary Feed Directive Final Rule
Today the U.S. Food and Drug Administration’s Center for Veterinary Medicine published a summary assessment for Veterinary Feed Directive (VFD) compliance activities conducted during fiscal years 2016-2018. [Source: FDA 29 August 2019]