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U.S. Department of Health and Human Services

For Industry

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Submission Statistics

FDA ESG 2006-2012 Total Submission Statistics
2006 - 2012 Totals2006200720082009201020112012Totals
AERS55,156159,562252,614300,672472,142557,917455,9962,254,059
CDER1,63911,17524,79745,51069,73993,50370,317316,680
CBER2941,5042,5574,4835,5886,3974,60425,427
CDRH1,5751,5274,61921,296119,087280,312316,307744,723
CVM 28884385994517,93225,29146,158
OC  18816,27548,23255,67642,365162,736
CTP   5223348391967
MWP    1,1382,5302,2635,931
Totals58,664174,056285,618389,100717,0941,014,615917,5343,556,681

 

FDA ESG 2012 Monthly Submission Statistics
 2012 
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS68,102 52,38152,62651,15157,52054,137  53,453 66,626    455,996
CDER7,4558,0549,4658,588 9,250 8,815 8,324 10,366    70,317
CBER470 518595594 607 563 636 621    

4,604

CDRH36,669 38,84353,23641,056 35,871 34,657 38,248 37,727    316,307
CVM3376 4,0482,6592,633 2,905 2,854 3,1263,690     25,291
OC6,649 4,8045,1015,023 5,093 5,1024,687  5,906    42,365
CTP79 7337 131 45 25 64     391
MWP272 344616287 586 56 44 58    2,263
Totals123,072 108,999124,301109,369 111,963 106,229 108,543 125,058    917,534

 

FDA ESG 2011 Monthly Submission Statistics

 2011 
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS47,160 37,282 47,73942,66545,939 49,65440,09454,154 40,69550,21756,387 45,931557,917
CDER6,320 7,248 8,2137,6498,008 8,251 7,6868,364 7,9997,858 7,9028,00593,503
CBER396 476 605466 536 574 534 611 533 530 5625746,937
CDRH20,194 13,374 17,27521,68019,567 20,075 27,47824,501 26,522 32,546 29,427 27,673280,312
CVM280 444 562516714 674 5652,920 3,498 3,240 2,827 1,69217,932
OC5,758 4,041 4,6384,3804,645 5,726 4,651 4,616 3,974 3,861 4,451 4,93555,676
CTP26 12 246 10 24 7 3 17 18 136 65348
MWP 160 171 183164 190 165 112 200 191 266 354 3742,530
Totals80,294 63,048 79,23977,526 79,609 85,143 81,127 95,369 83,429 98,536 102,046 89,2491,014,615

 

 

FDA ESG 2010 Monthly Submission Statistics
 2010 
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS28,80128,88931,71327,60127,30538,69767,08547,58742,622 35,51040,007 57,045 472,142
CDER4,1714,6605,7985,5815,6396,1365,6966,1955,980 6,2796,485  7,11969,739
CBER361427535457399555502477449476 441  5095,588
CDRH3,4656,1086,9047,1536,2178,18313,59012,09710,62018,096 11,905  14,749119,087
CVM781067393599067775167 74  110945
OC3,9043,0964,1143,6493,7455,7674,3014,4993,5193,415 3,457  4,76648,232
CTP1236143612017209 43223
MWP    106157106176130119  114 2301,138
Totals40,06143,30949,14344,54843,47359,64691,36771,125 63,39163,971 62,489  84,571717,094

 

FDA ESG 2009 Monthly Submission Statistics
 2009 
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS19,26121,03126,58122,15222,569 26,240 24,224 29,09730,467 25,24025,48028,330300,672
CDER2,2682,9983,2353,4083,493  3,6923,9894,075  4,1824,7584,5524,86045,510
CBER257261341338 290 362 363352  3654795175584,483
CDRH7008121,6421,5541,361  1,3451,694 1,339  2,4482,5293,2992,57321,296
CVM6073103103 70 709668 58 465557859
OC63701029685  840969 1,416  1,8522,6402,9715,17116,275
CTP           55
Totals22,60925,24532,00427,65127,868 32,549  31,335 36,34739,372 35,69236,87441,554389,100

 

FDA ESG 2008 Monthly Submission Statistics
 2008 
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS15,32517,88225,76021,63118,70321,96619,35921,52722,69120,00119,17028,599252,614
CDER1,3971,7201,6441,6951,7471,7832,1212,3282,3752,7182,4132,85624,797
CBER1531951682031942203012012232391772832,557
CDRH1151471442122462792573874519394031,0394,619
CVM6264707863101839041695072843
OC      215182427102188
Totals17,05220,00827,78623,81920,95324,34922,12324,54825,79923,99022,24032,951285,618

 

FDA ESG 2007 Monthly Submission Statistics
 2007 
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS9,5769,94812,15814,69612,91715,17712,54612,90614,92514,81013,56816,335159,562
CDER4576006507851,0099508801,1329301,2121,2581,31211,175
CBER6858851021011061191931491791811631,504
CDRH176108127102751388020526711870611,527
CVM      455835554649288
OC             
Totals10,27710,71413,02015,68514,10216,37113,67014,49416,30616,37415,12317,920174,056

 

FDA ESG 2006 Monthly Submission Statistics
 2006 
 MayJunJulAugSeptOctNovDecTotals
AERS9,1096,1885,1556,4085,6216,3937,7598,52355,156
CDER2054441192072834115011,639
CBER69193656496158294
CDRH153312272198952371721361,575
CVM         
OC         
Totals9,2886,5635,4906,7615,9796,9628,4039,21858,664

 

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