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OTC Drugs-Of-Abuse Assay Firms Should Provide Confirmatory Testing - Panel

This article was originally published in The Tan Sheet

Executive Summary

FDA should require manufacturers of OTC screening tests for drugs-of-abuse to cover the cost of confirmatory testing for presumptive positive results, members of FDA's Clinical Chemistry & Clinical Toxicology Devices panel recommended.

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FDA OTC Drugs Of Abuse Screening Kit Guide Clarifies Cost Bundling

FDA does not advise that OTC device manufacturers bundle the cost of primary and confirmation tests for home-use drugs of abuse test kits, the agency states in a draft guidance published in the Federal Register Dec. 2

FDA OTC Drugs Of Abuse Screening Kit Guide Clarifies Cost Bundling

FDA does not advise that OTC device manufacturers bundle the cost of primary and confirmation tests for home-use drugs of abuse test kits, the agency states in a draft guidance published in the Federal Register Dec. 2

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