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Wednesday, March 23, 2005At a time when the FDA has been under political fire for approving painkillers and other drugs that later had to be withdrawn, telling companies they are setting aside any data represents a potentially risky step for the agency and its acting commissioner, Lester Crawford. But Lesko said there have been no objections filed to the agency since it first proposed the new genomic-research guidelines in 2003. Eventually, the FDA may allow companies similar exemptions for other advanced laboratory techniques, he said. The idea of applying genomic research to drug development and patient care represents a medical breakthrough, but in practice advances have been slow to arrive. In recent years the FDA has approved a few treatments developed from genomics such as Novartis AG's Gleevec for leukemia and ImClone Systems Inc.'s cancer drug Erbitux. Lesko said the guidelines include safeguards to make sure firms won't take advantage of the assurance that early data won't affect later safety reviews. So far 10 companies have submitted genomic data under a draft of the guidelines. In just one of those cases, the agency told the company to resubmit the data under its standard review process because it could bear on the FDA's final marketability decision, he said. posted by Sydney on 3/23/2005 08:17:00 AM 0 comments 0 Comments: |
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