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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...
United StatesFood, Drugs, Healthcare, Life Sciences
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Biologic Products; Draft Guidance for Industry."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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