The U.S. Food & Drug Administration releases a list of pre-market approvals granted in October 2012.
Summary of PMA Originals & Supplements Approved
Summary of PMA Originals Under Review
Total Under Review: 51
Total Active: 21
Total On Hold: 30
Summary of PMA Supplements Under Review
Total Under Review: 555
Total Active: 392
Total On Hold: 163
Summary of All PMA Submissions Received
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 69
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 164
FDA Time: 123.6 Days MFR Time: 40.4 Days
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