GMP Cost Impact, Ephedra Suits Loom Over Supplement Industry – Israelsen
This article was originally published in The Tan Sheet
Executive Summary
The Office of Management & Budget likely is delayed in releasing GMPs because it is grappling with issues surrounding the economic impact of the rule on small businesses, according to UNPA head Loren Israelsen
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FDA’s use of sweeping guidance documents, such as the NDI notification draft, faces criticism from industry attorneys. The recent Franck’s Lab case, which FDA lost, could serve as a precedent for legal challenges of agency enforcement that tracks guidance.
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