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FDA Announces 2021 ADUFA and AGDUFA Fees
August 4, 2020, Covington Alert
On Friday, FDA announced the Animal Drug User Fees (ADUFA fees) and Generic Animal Drug User Fees (AGDUFA fees) for Fiscal Year 2021.
FDA Publishes Draft Guidance Proposing to Establish Standardized Assay Limits for Medicated Feeds
February 26, 2020, Covington Alert
Today, the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) published a draft Guidance for Industry (draft guidance) proposing to standardize assay limits for medicated feeds. CVM requests electronic or written comments concerning the draft guidance be submitted to the docket by April 27, 2020. The draft guidance recommends a standardized ...
February 14, 2020, Covington Alert
On February 13, 2020, the Food and Drug Administration (FDA) issued a draft guidance document describing the pre-submission consultation process for food additive petitions (FAPs) and generally recognized as safe (GRAS) notices for ingredients used in animal feed/pet food, and describing what to include in food use authorization (FUA) requests. The Animal Drug ...
November 27, 2019, Covington Alert
Last week, the United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) published Draft Guidance for Industry No. 256, “Compounding Animal Drugs from Bulk Drug Substances” (Draft Guidance).