- The FDA's Center for Veterinary Medicine issues new guidance that transfers regulatory jurisdiction for Intrexon (XON +1.3%) unit Oxitec's Friendly Aedes mosquito (OX513A) to the Environmental Protection Agency (EPA) since it is considered a pesticide product.
- FDA-CVM guidance clarifies "that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes, and that are not intended to cure, mitigate, treat or prevent a disease (including by an intent to reduce the level, replication or transmissibility of a pathogen in mosquitoes), are not "drugs" under the Federal Food, Drug, & Cosmetic Act, and will be regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act…With the issuance of final guidance #236, Oxitec Ltd's genetically engineered mosquito, with its proposed claim to control the population of wild-type Aedes aegypti mosquitoes, now falls under EPA's regulatory authority and all related regulatory questions should be directed to the EPA."
- Oxitec says once EPA registration is completed it will work with state and local authorities on the coordinated release of OX513A.