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FDA Publishes First Annual Report on Antibiotics Sold or Distributed for Use in Food-Producing Animals
December 15, 2010By Riëtte van Laack –
The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare annual summaries of antimicrobials sold or distributed for use in food-producing animals. The data are derived from information sponsors of new animal drug applications provide to FDA (as required by Sectin 105 of ADUFA). Last week, FDA published its first annual report summarizing the data. The report shows that approximately 29 million pounds of antibiotics for use in food-producing animals were sold in 2009. More than 9 million pounds of the antibiotics were tetracyclines. The report does not include anti-fungal or anti-viral drugs because, with the exception of formalin and hydrogen peroxide water immersion products, no approved anti-fungal or anti-viral products for use in food-producing animals were marketed in 2009.
The data on antimicrobial drugs sales and distribution information are intended to assist FDA in the Agency’s evaluation of antimicrobial resistance trends as well as FDA’s analysis of other issues that may arise relating to the safety and effectiveness of antimicrobial drugs approved for use in food-producing animals. Because this is the first report, meaningful trend analysis are not yet possible.
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- CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program June 2, 2023
- Another Mystery Solved: DEA Issues a Final Decision Revoking Morris & Dickson’s Registration: Or Has It? May 31, 2023
- HP&M to Co-Chair the Host Committee for the IBA World Life Sciences Conference May 25, 2023
- FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact May 24, 2023
- The End of the Road for the Skinny Label? May 24, 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
- Drug Enforcement Administration
- 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
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized