Cough/cold combinations
This article was originally published in The Tan Sheet
Executive Summary
Lil' Drug Store asks for agency feedback meeting on "methodology and appropriateness" of proposed clinical or equivalence studies on its Vaporizer in a Bottle product before commencing trials to support inclusion in the OTC cough/cold combination final monograph. Firm's June 19 letter requests input on in vitro and clinical study appropriateness and methodology; mobility/proximity; combination versus single ingredient formulation; and "statistical significance level required to demonstrate effectiveness." Final monograph was published December 2002 (1"The Tan Sheet" Dec. 23, 2002, p. 3)...
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