The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance document entitled “Informed Consent Information Sheet.” A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information. See: http://www.gpo.gov/fdsys/pkg/FR-2014-09-26/pdf/2014-22951.pdf Comments will be received through October 27, 2014. The draft guidance is available at the following web link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm404975.htm
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