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BLAs Will Be Required To Use Structured Product Labeling Within Year

Executive Summary

FDA plans to extend structured product labeling (SPL) requirements to all biologics submissions in roughly one year, CDER Office of Business Project Support Program Manager Lisa Stockbridge said

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The Structured Product Labeling Implementation Guide for FDA Content of Labeling Submissions Version 2a/Revision 1 has been released by the agency. The document is an interim implementation guide for the "SPL Release 2a" schema used by FDA for validating SPL submissions. The agency's "DailyMed" electronic labeling system will be implemented in November using the machine-readable structured product labeling format (1"The Pink Sheet" Oct. 3, 2005, p. 12)...

DailyMed E-Labeling System Completion Awaits Physician Label Final Rule

The "DailyMed" electronic labeling system will be implemented in November; however, up-to-date information will not be fully available for roughly one year, FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb said Sept. 28

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011





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