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Table of Contents
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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Draft Guidance for Industry – Safe Animal Feeding |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Draft Guidance for Industry - Ingredient Standard and Definitions FDAAA
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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Draft Guidance for Industry -Avian Influenza and Animal Feeds |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Draft Guidance for Industry -Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing |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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