FDA material time/extent proposal sets "more rigorous" standard for foreign data -- BASF.
This article was originally published in The Tan Sheet
FDA MATERIAL TIME/EXTENT PROPOSAL SETS "MORE RIGOROUS" STANDARD of safety for new conditions of use based on foreign use data than that which "has existed and now prevails for OTC products marketed in the U.S.," according to comments submitted to the agency by the D.C. office of Morgan, Lewis & Bockius on behalf of BASF AG. The comments respond to an Oct. 3 advance notice of proposed rulemaking in which FDA proposes to review data on substances marketed in other countries for possible inclusion in the U.S. monograph ("The Tan Sheet" Oct. 7, 1996, p. 1).
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