Zdrowie i gospodarka · 18.02.2015

Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period

The Food and Drug Administration (FDA) is announcing a 1-day public meeting entitled "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products." The purpose of the meeting is to provide a public forum for FDA to listen to comments on the proposed rule on "changes being effected" supplements that was published in the Federal Register of November 13, 2013, and alternatives offered to this proposed rule. FDA is also reopening the comment period for the proposed rule to receive submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.