United States:
FDA Extends Closing Date Of Intent To Participate In Consultation Of Reauthorization Of The Generic Drug User Fee Amendments Of 2012
15 September 2015
Jones Day
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In the August 12, 2015, Federal Register,
FDA announced that it is extending the closing date for public
stakeholders, health care professionals, and scientific and
academic experts to notify the FDA of their intent to participate
in periodic consultation meetings on the reauthorization of the
Generic Drug User Fee Amendments of 2012 ("GDUFA"). The
FDCA requires FDA to consult with a range of stakeholders in
developing recommendations for the next GDUFA program.
Closing Date is now April 30, 2016.
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