United States:
FDA Extends Comment Period For CMC Guidance Document
15 October 2015
Jones Day
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In the October 6, 2015, Federal Register, FDA
announced it is reopening the comment period for the
"Established Conditions: Reportable Chemistry, Manufacturing,
and Controls ("CMC") Changes for Approved Drug and
Biologic Products; Draft Guidance for Industry." Comments are
now due January 4, 2016.
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