FDA, Industry Collaborate On Genomics Guide
Last month, the FDA issued its long-awaited draft guidelines for pharmacogenomic data submission. Companies large and small have been anxious to get their hands on these guidelines, for they are a critical starting point in the agency’s efforts to come up with the most appropriate requirements for pharmacogenomic data as part of a new drug application (NDA), a biologics license application (BLA) or even an investigational new drug application (IND).
Canola Case Tests GMO Patent
The future of genetically modified crops in North America is in the hands of a 73-year-old Canadian canola farmer named Percy Schmeiser.
Schmeiser already has lost two court cases dealing with his use of seed designed by Monsanto, but he and his supporters have made it to the Supreme Court of Canada with a new argument: Monsanto’s patent is invalid.
Food Biotech Is Risky Business
The genetically modified food industry has battled opposition from consumer and environmental groups to get its food on the table. Its lobbyists have cajoled skeptical politicians; its scientists have produced studies contradicting other studies suggesting the food is somehow tainted.
Now the industry faces another hurdle with long-range, dire consequences: It may be uninsurable.