In US, Market Exclusivity For NDI Notifications ‘Just Not There’ In DSHEA Regulation
Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.
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FDA estimate “simply perpetuates the agency’s previous misunderstanding of the burden that NDI notifications impose,” says CRN CEO Steve Mister. FDA says its estimate is for costs of submitting information, not for studies to generate the information.
House legislation to exempt hemp-derived cannabinoids from FDA rule that an “article” previously studied or approved for use as drugs is not allowed for use in dietary supplements either resolves a conundrum or raises additional questions for the agency and the industry.
Steven Tave on 15 March will move from ODSP director to lead ORA’s Office of Strategic Planning and Operational Policy. Agency’s next commissioner, who Capitol Hill lobbyists say could be named next week, will appoint a replacement.