• FDA Releases Strategic Plan for Veterinary Medicine Program

    The US Food and Drug Administration (FDA) has released a new strategic plan for its veterinary medicine program for the 2012-2016 period, outlining the regulatory goals for FDA's Center for Veterinary Medicine. The plan, intertwined with FDA's plan for the Center for Food Safety and Applied Nutrition (CFSAN), provides seven "strategic program goals" and dozens of specific initiatives meant to carry out those strategic program goals. FDA's Foods and Veterinary Medicine...
  • FDA Seeks to Limit Antibiotics in Animal Feed

    The Food and Drug Administration has released guidance asking drug companies to voluntarily limit the use of certain antibiotics in animal feed in response to concerns that their overuse in livestock contributes to the development of drug-resistant bacteria.  "It is critical that we take action to protect public health," said FDA Commissioner Margaret A. Hamburg, MD. The agency has published three documents to address the issue: (1) A final guidance that...
  • FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism

    Shortly after the US Food and Drug Administration (FDA) released new rules to curtail the "injudicious" use of antibiotics in food-producing animals , three pharmaceutical manufacturers said they were agreeing to change the labeling on their veterinary antibiotics to exclude indications for food-producing animals, reports Bloomberg . FDA Deputy Commissioner for Foods Michael Taylor said he has assurances from Pfizer Inc., Eli Lilly & Co. and Merck & Co.-three o...
  • FDA Releases New Guidance To Voluntarily Limit Many Uses of Antibiotics in Animals

    The US Food and Drug Administration (FDA) released three new guidance documents that seek to phase out the "injudicious use" of antibiotics in food-producing animals through voluntary actions through voluntary actions by industry. The guidances follow an order in late March 2012 by US Magistrate Judge Theodore Katz for FDA to remove antibiotics from animal feed or withdraw the non-therapeutic uses of those drugs entirely . The newly-released guidance calls for "judici...
  • New FDA Guidance on Evaluation of Veterinary Stability Data

    A new draft guidance for industry out of the US Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) aims to implement the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products' (VICH) GL51 quality measure. The draft guidance, Statistical Evaluation Of Stability Data (VICH GL51) , was released 4 April and deals with Step 4 of VICH's 9-step procedure . "This draft guidance is intended...
  • FDA Releases New Veterinary CMC Guidance

    The US Food and Drug Administration (FDA) is releasing new guidance for industry for chemistry, manufacturing and controls (CMC) information relating to fermentation-derived products, including intermediates, drug substances and related drug products for veterinary medicinal use. The guidance "provides recommendations on what documentation to submit to support the [CMC] information" for veterinary products to the Center for Veterinary Medicine (CVM). "This information i...
  • FDA Developing New Standardized Form for GRAS Submissions, Seeks Comment

    A Federal Register posting today by the US Food and Drug Administration (FDA) is soliciting comments on the food additive Notification Procedure for Substances Generally Recognized as Safe (GRAS) and its new Form FDA 3667. In particular, FDA invites comments on whether information sought by FDA is necessary, onerous, adequate or efficient. FDA currently regulates food additives through a premarket approval system. Exemptions from this system may be sought by companie...