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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 2009)

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 2009. 

Center for Veterinary Medicine
2009 Guidance Agenda

Draft Guidance for Industry – Safe Animal Feeding

Phares Okelo, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, MPN4, Rm. 2661 Rockville, MD 20855, 240-453-6862,  phares.okelo@fda.hhs.gov

Draft Guidance for Industry - Ingredient Standard and Definitions FDAAA

Mika Alewynse, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, MPN4, Rm. 2632, Rockville, MD 20855, 240-453-6866, mika.alewynse@fda.hhs.gov

Draft Guidance for Industry -Avian Influenza and Animal Feeds

Al Montgomery, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, MPN4, Rm. 2666 Rockville, MD 20855, 240-453-6836, al.montgomery@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,  240-453-6865  william.burkholder@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Draft Guidance for Industry -Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing

Arnel Peralta, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, MPN4, Rm.2622, Rockville, MD 20855, 240-276-9066, amel.peralta@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

Final Guidance for Industry – Documenting Statistical Analyses

Anna Nevius, Center for Veterinary Medicine (HFV-105), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8170; e-mail:  anna.nevius@fda.hhs.gov

Final 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,  240-276-8105, suzanne.sechen@fda.hhs.gov

Final 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,  240-276-8331, germaine.connolly@fda.hhs.gov

Draft Guidance for Industry - Fermentation Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use—Chemistry, Manufacturing, and Controls Information

Michael Popek, Center for Veterinary Medicine (HFV-144), Food and Drug Administration, 7500 Standish Place, MPN-2, Rm. E335, Rockville, MD 20855, 240-276-8269, michael.popek@fda.hhs.gov

Draft Guidance for Industry -Active Controls in Studies to Demonstrate the Effectiveness of a New Drug for Use in Companion Animals

Lisa Troutman, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Place, MPN-2, Rm. N319, Rockville, MD 20855, 240-276-8322, lisa.troutman@fda.hhs.gov

Draft Guidance for Industry –  Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products, VICH GL-45

Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, MPN-2, Rm. E334, Rockville, MD 20855,  240-276-8268, dennis.bensley@fda.hhs.gov

      


Web Page Updated by jmo - April 24, 2009 7:00 am ET




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