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Table of Contents
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A sponsor can apply for Designation status for Minor Use and Minor Species drugs prior to their approval or conditional approval. If a drug is designated for MUMS purposes, the sponsor of the drug obtains seven (7) years of marketing exclusivity upon approval (or conditional approval) of the drug. Each designation that is granted must be unique, i.e., only one sponsor can be designated for a particular drug substance in a particular dosage form for a particular intended use. The Center is following the final rule for designations to administer this provision. The final rule lays out how to apply for designation, what needs to be submitted and other information pertaining to this option.
MUMS Drug Designations List
CVM Updates/FDA News
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CVM Update - FDA Issues a Notice of Proposed Rule Making Defining Small Number of Animals for Minor Use Designation, March 18, 2008
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CVM Update - FDA Publishes Final Rule on Designation of New Animal Drugs for Minor Uses or Minor Species, July 26, 2007
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CVM Update - FDA Approves New Antimicrobial for Catfish, October 25, 2005
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CVM Update - FDA Grants First Minor Use and Minor Species Drug Designations, October 6, 2005
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CVM Update - FDA Issues Proposed Regulations for MUMS Designation, September 27, 2005
Federal Register Notices
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Proposed Rule - Docket No. 2008N-0011, CVM 200775. Defining Small Number of Animals for Minor Use Designation. Pages 14411-14417 [FR Doc. E8-05385] March 18, 2008 [TXT] [PDF] [PRE-PUB] Comments due July 16, 2008
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Final Rule - Docket No. 2005N-0329, CVM 200641. Designation of New Animal Drugs for Minor Uses or Minor Species. Pages 41010-41022 [FR Doc. E7-14444 ] July 26, 2007 [TXT] [PDF] [PRE-PUB] Effective date October 9, 2007
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Proposed Rule - Docket No. 2005N-0329, CVM 200589. Designation of New Animal Drugs for Minor Uses or Minor Species; Reopening of the Comment Period. Page 76732 [FR Doc. 05-24512] [TXT] [PDF] [PRE-PUB] Comments due January 27, 2006
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Proposed Rule - Docket No. 2005N-0329, CVM 20053. Designation of New Animal Drugs for Minor Uses or Minor Species. Pages 56394-56409 [FR Doc. 05-19196] September 27, 2005 | htm | | pdf | Comments on document by December 12, 2005 Comments on information collection due October 27, 2005
Web Page Updated by mdt - March 19, 2008, 1:05 PM ET
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