- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 2023
- HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval March 19, 2023
- It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2 March 17, 2023
- FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations March 16, 2023
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FDA Finalizes Guidance on Mosquito-Related Products (Including Genetically Engineered Mosquitoes)
October 24, 2017By Ricardo Carvajal —FDA finalized a guidance that clarifies FDA and EPA jurisdiction over mosquito-related products, including mosquitoes produced through the use of biotechnology. FDA had issued the draft guidance as part of a batch of biotech-related documents that were released in the final days of the Obama administration (see our prior post here).
The final guidance takes greater pains to explain the factors that govern whether FDA or EPA have jurisdiction over a given product, and makes explicit the conclusion that “products intended to reduce the population of mosquitoes” are pesticide products regulated by EPA – regardless of “whether the product is a traditional chemical product or involves a different technology (e.g., a recombinant DNA construct or bacteria intended to reduce the population of mosquitoes)” (emphasis ours). Consistent with that conclusion, FDA announced that Oxitec’s genetically engineered mosquito falls under EPA’s regulatory authority because it claims to control the population of a certain species of mosquito. As we discussed in a prior posting, FDA had given a green light to investigational release of the Oxitech mosquito. In accord with the final guidance, FDA will have no further involvement in the regulation of the Oxitech mosquito, absent a change in its intended use.
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- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 2023
- HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval March 19, 2023
- It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2 March 17, 2023
- FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations March 16, 2023
- Ricardo Carvajal to Moderate Panel at FDLI’s Food and Dietary Supplement Safety and Regulation Conference March 16, 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