Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft
By
Dan Schiff / Email the Author / “The Tan Sheet” Feb. 6, 2012, Vol. 20, No. 06
Regulatory / Word Count: 1782 / Article # 05120130023
Executive Summary
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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