The U.S. Food & Drug Administration releases a list of pre-market approvals granted in November 2012.
Summary of PMA Originals & Supplements Approved
Summary of PMA Originals Under Review
Total Under Review: 49
Total Active: 18
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 640
Total Active: 480
Total On Hold: 160
Summary of All PMA Submissions Received
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 92
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 140
FDA Time: 98.7 Days MFR Time: 41.3 Days
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