Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies and Companion Guidance Document; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Reopening of the Comment Period

摘要

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability, published in the Federal Register of March 27, 2008. In that document, FDA requested comments on two draft guidance documents entitled "Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies" and "Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies Draft Companion Guidance Document." The Agency is reopening the comment period to allow interested persons to provide updated comments and any new information.