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12:00 AM
Nov 03, 2003
 |  BioCentury  |  Politics, Policy & Law

FDA's genomics safe harbor

FDA is beginning to unveil the specific directions it wants to take on the use of genetic information in testing, regulatory decision making and clinical use of drugs, starting today with a draft guidance on the submission of pharmacogenomic data.

The heart of the new guidance is a proposed policy on "voluntary genomic data submissions" (VGDS), which FDA has been crafting in consultation with biotech and pharma companies. The idea is to create a safe harbor by assuring sponsors that regulatory decisions will not be made based on experimental genomic data.

Although the policy would give the agency latitude to require the use of VGDS data when it is subsequently validated by the science, FDA promises that if it receives exploratory genomic data, it will not halt a product's development or review process and force a company to determine what the data mean.

The safe harbor thus would assure sponsors that they will not be penalized for submitting data hinting that an identifiable...

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