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Cervical Cancer
SpectRx, Inc. holds pre-PMA meetings with U.S. FDA on painless cervical cancer test
February 27th, 2007
SpectRx, Inc. (SPRX) announced it has held its preliminary premarket approval application (PMA) meetings with the U.S. Food and Drug Administration (FDA) to ensure the data, data format and supporting documentation of a PMA application will meet standards and expectations of the agency and its advisory panel. "The Pre-PMA meetings represent an important milestone for the company in the process of securing U.S. regulatory approval to market our noninvasive cervical cancer detection product," said Mark Faupel, PhD, SpectRx president and chief operating officer. "As we work toward completing subject enrollment in the pivotal trial, we expect to receive...
Source: Cancer Weekly (2007-02-27)
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