FDA cough/cold monograph
This article was originally published in The Tan Sheet
Executive Summary
Sept. 11 "feedback" meeting set for Vaporizer in a Bottle marketer Lil' Drug Store, FDA says. The meeting will take place at 2 p.m. at 9201 Corporate Blvd., Rockville, Md. Firm is seeking guidance on proposed clinical trial methodologies on the combination antitussive product to gain inclusion in the OTC Drug Cough, Cold, Allergy, Bronchodilator & Antiasthmatic Combination Drug Product Final Mongraph as an antitussive (1"The Tan Sheet" Aug. 4, 2003, In Brief)...
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Cough/cold combinations
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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