Published in FDA Law Weekly, November 17th, 2005
Gen-Probe expected to receive a "complete review letter" from the FDA by October 31, 2005. Based on the time it could take Gen-Probe to respond to questions in this letter and the time for FDA to evaluate the responses, Gen-Probe believes approval of the assay on the enhanced semiautomated system may be delayed into 2006. Gen-Probe's previous guidance that the BLA was on track for approval by the end of this year was based on...
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