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FDA turns down OTC (over-the-counter) home test for total cholesterol

This article was originally published in Clinica

Executive Summary

Technical Chemicals and Products (TCPI) has failed in its attempt to gain US FDA clearance to market an over-the-counter version of its HealthCheck screening test for total cholesterol. This setback means it could be several months before the company is ready to resubmit another marketing application for the test kit.

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