NDI Notifications Take Center Stage In FDA's Evaluation Of DSHEA
FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.
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Why stakeholders have many questions and why so many ingredients that weren’t cleared by FDA are rampant in the US are questions at the heart of resolving disagreement between the industry and the agency over regulation both sides acknowledge is biggest impediment to market growth.
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.
US Wellness Market In 2019: Amarin Wins, Loses On Supplements; Gottlieb Leaves With Consumer Health Flourish
Looking look back on US wellness market developments and events in 2019, HBW Insight finds a firm that doesn’t compete in the dietary supplement sector, Amarin, made a good bit of news that affected the industry during the year. We track news across the wellness space from the past year.