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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).

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.

NBI On Drugs
You won’t recognize the Nasdaq Biotechnology Index (NBI) the next time you see it. It’s undergone a radical change, bulking up to nearly twice its original size by adding 55 more companies to the list. The new Index, which debuted November 24, now consists of 129 firms � and many of the new additions are drug companies (including specialty pharmas and generic drug manufacturers).