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| Specifications | GFI 191 - Changes to Approved NADAs \204New NADAs vs. Category II Supplemental NADAs GFI 191 - Changes to Approved NADAs \204New NADAs vs. Category II Supplemental NADAs GFI 191, Approved NADAs , Category II Supplemental NADAs, CVM, guidance, ONADE CVM |
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| Specifications | GFI 191 - Changes to Approved NADAs \204New NADAs vs. Category II Supplemental NADAs GFI 191 - Changes to Approved NADAs \204New NADAs vs. Category II Supplemental NADAs GFI 191, Approved NADAs , Category II Supplemental NADAs, CVM, guidance, ONADE CVM |
| Outline | I. INTRODUCTION II. BACKGROUND III. DEFINITIONS IV. NEW NADA OR CATEGORY II SUPPLEMENTAL NADA — WHICH IS BEST? A. New Active Pharmaceutical Ingredient (API) — Submit as New NADA B. New Dosage Form — Submit as New NADA C. New Major Route of Administration — Submit as New NADA D. Adding Species/Classes of Animals — Submit as a Category II Supplemental NADA E. Adding or Changing Doses — Submit as a Category II Supplemental NADA F. Changing Dosing Schedule — Submit as a Category II Supplemental NADA G. Adding Indications/Claims — Submit as a Category II Supplemental NADA H. Changing (Rx, OTC, VFD) Status — Submit as a Category II Supplemental NADA I. Replacing, Adding, Deleting, or Changing Concentrations of Inactive Ingredients J. Changing Concentrations of Active Ingredients K. Multiple Changes |
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| Content | #191 Guidance for Industry Changes to Approved NADAs — New NADAs vs. Category II Supplemental NADAs FINAL GUIDANCE Comments and suggestions regarding this document should be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the Docket No. FDA-2008-D-0614. For questions regarding this document, contact Suzanne J. Sechen, Center for Veterinary Medicine, HFV-126, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8105, e-mail: suzanne.sechen@fda.hhs.gov Additional copies of this guidance document can be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at http://www.fda.gov/AnimalVeterinary/default.htm. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine November 19, 2009 |
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| Following Datasheets | UCM053308_1 (1 pages) UCM053338_1 (2 pages) UCM053435_1 (2 pages) UCM053438_1 (2 pages) UCM053453_1 (1 pages) UCM053459_1 (1 pages) UCM053474_1 (1 pages) UCM053493_1 (1 pages) UCM053528_1 (3 pages) UCM053529_1 (1 pages) |
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