The Food and Drug Administration (FDA) has announced the availability of revised guidance for industry concerning the use of veterinary feed directive drugs. The Guidance for Industry #120 has been revised to provide more detailed information on transmitting electronic veterinary feed directive (VFD) orders via the Internet.
Category Archives: FDA
FDA Rescinds Order Banning the Extralabel use of Cephalosporins
The U.S. Food and Drug Administration (FDA) is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. FDA received many substantive comments following issuance of the order of prohibition and is taking this action so that it may fully consider these comments.
FDA Rescinds Order Banning the Extralabel use of Cephalosporins
The U.S. Food and Drug Administration (FDA) is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. FDA received many substantive comments following issuance of the order of prohibition and is taking this action so that it may fully consider these comments.
President Bush Signs Reauthorization of ADUFA and Authorization of AGDUFA
On August 14, 2008, President Bush signed the Animal Drug User Fee Amendments of 2008 (ADUFA).
FDA and the Veterinarian
The Center for Veterinary Medicine (CVM) within the Food and Drug Administration (FDA) has published a booklet describing how the CVM interacts with the veterinary profession. The booklet is available online at the CVM website.
FARAD Needs Your Urgent Support
The AVMA has joined with food animal veterinary groups and livestock production organizations to seek multi-year funding to support the Food Animal Residue Avoidance Databank (FARAD). Although authorized in the 2008 Farm Bill, FARAD has not received permanent funding. Operations will be forced to shut down in September unless funding can be found. The AVMA is requesting your help.
FDA Commissioner Names Directors to Food Safety and Veterinary Centers
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., is pleased to announce two major changes in the agency’s senior leadership team. Effective Monday, Stephen F. Sundlof, D.V.M., Ph.D., is moving from director of FDA’s Center for Veterinary Medicine (CVM) to director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Bernadette Dunham, D.V.M., Ph.D., who is deputy director of CVM, will assume directorship of CVM, also effective Monday.
FDA Schedules Public Meeting to Discuss NARMS
The U.S. Food and Drug Administration (FDA) has announced a public meeting to discuss the National Antimicrobial Resistance Monitoring System (NARMS).
FDA Provides Guidelines for Swine Respiratory Disease Studies
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) has published draft guidance document No. 178 entitled RECOMMENDED STUDY DESIGN AND EVALUATION OF EFFECTIVENESS STUDIES FOR SWINE RESPIRATORY DISEASE CLAIMS, DRAFT GUIDANCE providing recommendations to industry relating to study design and describes the criteria that the CVM intends to use to evaluate effectiveness studies for swine respiratory disease (SRD) claims. CVM uses the term SRD to refer to the component of acute respiratory disease in swine associated with bacterial pathogens and does not consider SRD synonymous with “Enzootic Pneumonia”, “Porcine Respiratory Disease Complex” (PRDC), or any other complex or syndrome.
Public Hearing to Discuss the Animal Drug User Fee Act
The US Food and Drug Administration (FDA) has announced a public meeting to be held February 24, 2006 to hear comments regarding the overall performance of the Animal Drug User Fee Act (ADUFA) in preparation for its reauthorization by Congress.