DailyMed Slated For October Launch, OND’s Jenkins Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s electronic labeling initiative is slated for an October launch, Office of New Drugs Director Jenkins says. Transition to structured product labeling format is central in launching DailyMed.
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FDA E-Labeling Guidance Sets Fall Goal For "Structured Product Labeling" Implementation
The final guidance provides three resources companies can access for assistance with SPL. FDA expects label changes for approved drugs will be submitted electronically using SPL by fall; the agency has not yet established a timeframe for unapproved drug labels.
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