Latest News From FDA

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

“ACTPs have the potential to make significant changes in how we treat diseases and may provide novel therapies for unmet therapeutic needs of animals,” reports Dr. Janet Woodcock, Acting Commissioner of the FDA.

Changes to the use conditions of these products will be based on science and available evidence, and the FDA believes this RFA will help generate such information.
FDA Offers Funds for Duration of Use Studies

Research needed to help define duration of use for certain medically important antimicrobial drugs for food animals.

The U.S. Food and Drug Administration continues to work with stakeholders to address antiparasitic resistance in livestock (cattle, sheep, goats, swine, and poultry) and horses.
FDA Continues to Address Antiparasitic Resistance in Livestock

Parasites are becoming increasingly resistant to drugs that were generally effective against them in the past.

The new draft guidance is titled “Compounding Animal Drugs from Bulk Drug Substances.”
FDA Hosts Webinar on Animal Drug Compounding

On November 21, 2019, at 1:00-2:30 p.m. EST, the FDA's Center for Veterinary Medicine will hold a public webinar about the agency’s newly-released draft Guidance for Industry #256.

The site includes graphic illustrations showing trends associated with the five-year plan.
FDA Announces Veterinary AMR Performance Measures on FDA-TRACK

Performance measures track the progress of the Center of Veterinary Medicine’s (CVM) Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings.

The U.S. Food and Drug Administration this week released draft Guidance for Industry, entitled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.”
FDA Issues Draft GFI on Conditional Drug Approvals

Expanded conditional approval has the potential to incentivize drug development and provide veterinarians with legally marketed new animal drugs.

The comment period will now close on January 6, 2020.
FDA Extends Comment Period on Withdrawal Times

On September 11, 2019, the FDA extended the comment period for its request for public input on zero-day withdrawal periods and zero-day milk discard times for animal drugs.

The posting will include reports associated with approved animal drugs, unapproved/compounded drugs used in animals and devices used in animals.
FDA Opens Adverse Event Report Data

In its continuing commitment to increase transparency, the FDA’ Center for Veterinary Medicine (CVM) announced this week the availability of data from over 30 years of adverse event reports related to animal drugs and devices used in animals.

Updating the dosage regimens of the affected approved animal drug products is a significant scientific and technical challenge.
FDA Offers Funding for Duration-of-Use Studies

The FDA this week announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals.

The webinar will focus primarily on current scientific evidence, promising uses of this technology in animals, and the potential risks.
FDA Reschedules Webinar on Genome Editing in Animals

This webinar is rescheduled from the original date of December 3, 2018.