FDA Lets Companies Review Docs For Unapproved Tobacco Products

FDA now will make it easier for companies to obtain the review documents the agency uses when it decides not to approve certain tobacco products based on a lack of evidence of substantial equivalence to a predicate tobacco product, the agency announced Tuesday (Aug. 14). FDA Commissioner Scott Gottlieb says the action will help make FDA's approval process more transparent for companies that receive “not substantially equivalent” (NSE) determinations from FDA. However, one leading consumer advocacy group says it is...