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Professional use kits

This article was originally published in The Tan Sheet

Executive Summary

"In the absence of data, FDA would not consider an exemption" from the OTC labeling final rule for products intended for professional use "based solely on the addition of certain qualifying statements in the labeling," agency says in Oct. 28 letter to D.C. law firm Kleinfeld, Kaplan & Becker. FDA says it is "unaware of data or information providing evidence that granting such an exemption would not compromise the safety and effectiveness of these products." In a July 26 letter, firm sought an official FDA statement on the addition of text, such as "for hospital/professional use only," that would qualify such products for exemption from some or all OTC labeling requirements. In response, agency says exemption request's scope is unclear and law firm does not provide sufficient basis for FDA to issue guidance...
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