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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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Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft

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.

Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft

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