The U.S. Food & Drug Administration releases a list of pre-market approvals granted in September 2012.
Summary of PMA Originals & Supplements Approved
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 30
Total On Hold: 27
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 581
Total Active: 443
Total On Hold: 138
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 78
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 145.7
FDA Time: 104.9 Days MFR Time: 40.8 Days
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