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Guidance Documents Under Development

CVM Guidance Documents Under Development
(expected to publish as drafts or finals by the end of December 2008)

Introduction
 
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the CVM is considering. We currently intend to develop guidance on each topic; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list. Topics on the list remain as projects until they publish as final guidance.

CVM Guidance Documents Under Development list has been updated to include those documents expect to publish by the end of 2008.  FDA also publishes an agency-wide Annual Guidance Agenda which includes CVM's Guidance Documents Under Development and is available for public comment.  

Center for Veterinary Medicine
2008 Guidance Agenda

Final Guidance - Regulation of Genetically Engineered (GE) Animals Containing Heritable nDNA Constructs

Larisa Rudenko, Center for Veterinary Medicine (HFV�0), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301�7�04, email: larisa.rudenko@fda.hhs.gov

Draft Compliance Policy Guide - Labeling And Marketing Of Nutritional Products For Dogs And Cats Intended To Diagnose, Cure, Mitigate, Treat, Or Prevent Diseases 

William J. Burkholder, Center for Veterinary Medicine, Food and Drug Administration, (HFV-228), 7519 Standish Place, MPN-4, Rm. 2642, Rockville, MD  20855,  william.burkholder@fda.hhs.gov.

Draft Compliance Policy Guide -Veterinary Drug Compounding

Neal Bataller, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Place, MPN-4, Rm. 143, Rockville, MD 20855, 240-276-9201,  neal.bataller@fda.hhs.gov

Final Compliance Policy Guide - Voluntary Self Inspection of Medicated Feed Manufacturing Facilities 

Paul Bachman, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Place, MPN-4, Rm. 143, Rockville, MD 20855, 240-276-9225,   paul.bachman@fda.hhs.gov.

Draft Compliance Policy Guide - Salmonella Contamination of Feeds

Xin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, MPN-4, Rm. 221, Rockville, MD 20855, 240-453-6863, Xin.Lin@fda.hhs.gov  

Draft Guidance - Criteria for Evaluating Tests for Detection of Animal Proteins Prohibited in Ruminant Feed

Dragan Momcilovic, Center for Veterinary Medicine (HFV-220), 7519 Standish Place, MPN-4, Rm. 227, Rockville, MD  20855, 240-453-6856, dragan.momcilovic@fda.hhs.gov

Draft Compliance Policy Guide Glucosamine/Chondroitin Animal Products

Paul Bachman, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Place, MPN-4, Rm. 143, Rockville, MD 20855, 240-276-9225,   paul.bachman@fda.hhs.gov

(VICH); Final Guidance for Industry - Target Animal Safety for Veterinary Pharmaceutical Products GL-43

Laura Hungerford, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Place, MPN-2, Rm. E375, Rockville, MD 20855, 301-827-6439, laura.hungerford@fda.hhs.gov

Draft Guidance for Industry- Submission of Veterinary Adverse Drug Event Reports to the Center for Veterinary Medicine, Form FDA 1932

Lynn Post, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Place, MPN-4, Rm. 2612, Rockville, MD  20855, 240-276-9062, lynn.post@fda.hhs.gov

Draft Guidance for Industry - Submission of Drug Experience Reports  (DER) to the Center for Veterinary Medicine, Form FDA 2301

Lynn Post, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Place, MPN-4, Rm. 2612, Rockville, MD 20855, 240-276-9062,  lynn.post@fda.hhs.gov

Draft Guidance for Industry � Documenting Statistical Analyses

Bob Abugov, Center for Veterinary Medicine (HFV- 105), Food and Drug Administration, 7500 Standish Place, MPN-2, Rm. N416, Rockville, MD 20855,  301-827-4356, robert.abugov@fda.hhs.gov

Draft Guidance for Industry � Changes to Approved NADAs - new NADA or Supplemental NADA

Suzanne Sechen, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Place, MPN-2, Rm. N448, Rockville, MD 20855,  301-827-0221, suzanne.sechen@fda.hhs.gov

Draft Guidance for Industry � Antimicrobial Drugs to Treat Companion Animals � Effectiveness Field Studies

Linda Wilmot Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Place, MPN-2, Rm. N316, Rockville, MD 20855, 301-827-7540, linda.wilmot@fda.hhs.gov

Draft Guidance for Industry � Anesthetics to Treat Companion Animals

Germaine Connolly, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Place, MPN-2, Rm. N331, Rockville, MD 20855,  301-827-7540, germaine.connolly@fda.hhs.gov

Draft Guidance for Industry - Drug Residues Resulting From the Extralabel Use of Approved New Animal Drugs #186

Deborah Cera, Center for Veterinary Medicine (HFV-235), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9209, deborah.cera@fda.hhs.gov

Draft Compliance Policy Guide - Common or Usual Names for Animal Feed Ingredients and Their Use in Animal Feed (CPG 7126.08)

Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Place, Rm. 2648, Rockville, MD 20855, 240-453-6864, sharon.benz@fda.hhs.gov

Draft Compliance Policy Guide -Importation of New Animal Drugs by Licensed Veterinarians;

Nadine Steinberg, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, MPN4, Rm. 2658, Rockville, MD 20855, 240-453-6846, nadine.steinberg@fda.hhs.gov

Draft Compliance Policy Guide - Marketed Unapproved New Animal Drugs

Nadine Steinberg, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, MPN4, Rm. 2658, Rockville, MD 20855, 240-453-6846, nadine.steinberg@fda.hhs.gov

      


Web Page Updated by jmo - October 16, 1:06 PM ET




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