HiFi DNA Tech’s Suit Against FDA Suggests Agency Misses HPV-Cervical Cancer Risk Link

Oct 24, 2007

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HiFi DNA Tech has sued the US Food and Drug Administration for allegedly failing to respond in time to a petition to down-classify its PCR-based human papillomavirus genotyping test, leading the company to claim that the agency’s regulatory approach is out of step with current scientific thinking about the link between HPV and cervical cancer.

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