Cancer Vaccines

HiFi DNA Tech Files Lawsuit Against FDA Over Inaction in Reclassification of Human Papillomavirus (HPV) Polymerase Chain Reaction (PCR) Test

Published in Drug Law Weekly, October 30th, 2007

A lawsuit was filed Oct. 12 in U.S. District Court against the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) related to reclassification of HPV DNA tests from class III to class II devices. The inaction by both agencies hinders introduction of new and affordable HPV testing to improve women's health care.

The suit was filed by a manufacturer of DNA test reagents, HiFi DNA Tech through its president, Sin Hang Lee, MD, a Connecticut pathologist. The complaint for relief was filed in U.S. District Court for the District of Connecticut in Bridgeport, CT.

"The inaction of both federal agencies blocks...

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Source: Drug Law Weekly (2007-10-30)

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