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)...
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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
