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FDA Approves First Biological Product Derived From Genetically Engineered Animals
February 9, 2009By Ricardo Carvajal –
FDA has approved the biological product ATryn, an anticoagulant derived from the milk of genetically engineered ("GE") goats. The approval follows on the heels of the agency’s issuance of long-awaited guidance on its regulatory approach to GE animals, which we discussed in a prior posting. Responses to the agency’s approval of ATryn are already raising concerns about animal welfare, environmental effects, and food safety. FDA’s press release attempts to address all of these concerns.
With respect to food and feed safety, the approval of ATryn is conditioned on exclusion of the goats from the food and feed supply. A Freedom of Information summary of the NADA lists the following as control measures supporting a conclusion that there exists a “reasonable certainty” that the GE goats won’t enter the food supply:
• Secure locked fencing around the entire facility, with double fencing around animal paddocks;
• Well maintained secure barns leading to fenced paddock and exercise yards;
• Round-the-clock staffing of the facility;
• Active on-site security with personnel supplemented with video surveillance;
• SOPs for animal identification and disposal that include procedures to ensure that all GE animals are identified by ear tag, tattoo, and implanted identification chip;
• all animals are incinerated at termination use.
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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 2024
- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 2024
- 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
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- Government Pricing
- Hatch-Waxman
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- 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