Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued Warning Letters to four companies concerning the illegal sale of unapproved animal drugs containing cannabidiol (CBD) intended for use in food-producing...more
The wait is finally over. On April 14, 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...more
On March 7, 2022, the U.S. Food and Drug Administration (“FDA”) announced its “low-risk determination” to clear the marketing of food products derived from beef cattle that have been genetically altered to be more tolerant of...more
The California Veterinary Medical Board has proposed amending the California Code of Regulations to clarify the process for veterinarians to compound drugs in a veterinary office for the treatment of an animal patient. As...more
On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more
Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more
On May 18, 2015, the U.S. Food and Drug Administration (“FDA”) withdrew its 2003 Compliance Policy Guide – Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding...more
The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more