Firms can get more FDA feedback on genomic research

The FDA outlined just how pharmaceutical and biotechnology firms should present genomic-based drug research. The FDA also created a process in which companies could submit preliminary data the agency said it wouldn't hold against drug companies later in the marketing review process. Larry Lesko, the FDA's director of clinical pharmacology, said the exemption will let firms start talks with the FDA earlier in the development process and make it easier to spot problems.

Boston.com / Business / Rules aim to speed personal medicine

BioBOOM Op/Ed: This is a tremendous regulatory development and opportunity that will affect the market. Watch the investment money flow to the emerging MDx and tool companies that have options and tests for just such needs. And it again highlights the potential for Roche's P450 chip

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