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FDA Lays Out In Vivo Absorption Trial Criteria For OTC Topical Drugs

May 10, 2019
In a final guidance document released Thursday (May 9), FDA lays out ways for sponsors of over-the-counter (OTC) topical drugs to conduct in vivo absorption trials that will help the agency determine whether a product is eligible to be included in OTC monograph. Industry, especially sunscreen makers, have expressed concern about such trials, saying the requirements mandate excessive levels of unusual testing. However, when the draft version of Thursday’s guidance was released in May 2018 , one lawyer representing sunscreen...


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