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MUMS Update- FDA Publishes Final Rule Defining “Small Number of Animals”
August 27, 2009By Susan J. Matthees –
After years of anticipation, FDA has finally published a final rule establishing a specific small number of animals for each of the seven major species for purposes of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act). The final rule, codified in 21 C.F.R. § 516.3(b), defines a small number of animals as “equal to or less than 50,000 horses; 70,000 dogs; 120,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000 turkeys; and 72,000,000 chickens.”
In the Federal Register notice announcing the final rule, FDA explained that the agency will “periodically reevaluate the definition of ‘small number of animals’” because the number of animals affected by a disease may change over time. FDA also noted that the agency could change the definition if the development cost versus market value of the drug changes. FDA will make any changes to the definition through proposed rulemaking.
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- To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA September 19, 2023
- Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats September 18, 2023
- HP&M’s Faraz Siddiqui to Speak at Informa’s Medicaid Drug Rebate Program (MDRP) Summit 2023 on Value Based Programs September 15, 2023
- Join Us for an HPM Webinar: Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45 September 13, 2023
- 510(k) Modernization 2023 September 12, 2023
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
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- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
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- Uncategorized