RAPS Annual Conference In Brief
This article was originally published in The Tan Sheet
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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
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
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.