For Industry

Submission Statistics

FDA ESG 2006-2016 Total Submission Statistics
 20062007200820092010201120122013201420152016Totals
AERS55,156159,562252,614300,672472,142557,917717,345876,4751,026,3141,321,114437,5556,176,866
CDER1,63911,17524,79745,51069,73993,503107,681124,232139,322159,51541,152818,265
CBER2941,5042,5574,4835,5886,3976,9278,4129,50611,2943,51660,478
CDRH1,5751,5274,61921,296119,087280,312462,316666,927812,4431,478,524329,3564,177,982
CVM 28884385994517,93235,42940,24143,77650,73812,576203,627
OC  18816,27548,23255,67664,28565,43068,17160,94313,041392,241
CTP   52233486421,2373247341393,652
MWP    1,1382,5302,4997378311,86371110,309
ACA      62207195212141817
GDUFA      2,7712,9263,5472,9065612,206
CFSAN      4584,2202,7563,76187512,070
HC       3245,8359,3663,64319,168
Totals58,664174,056285,618389,100717,0941,014,6151,400,4151,791,3682,113,0203,100,970842,76111,887,681
FDA ESG 2016 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS131,928181,075124,552         437,555
CDER11,83614,28315,033         41,152
CBER9091,1461,461         3,516
CDRH102,904105,441121,011         329,356
CVM3,8363,9044,836         12,576
OC4,3964,2214,424         13,041
CTP229621         139
MWP147369195         711
ACA67128         141
GDUFA142121         56
CFSAN241321313         875
HC9761,2241,443         3,643
Totals257,215312,108273,438000000000842,761
FDA ESG 2016 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS131,928181,075124,552         437,555
CDER11,83614,28315,033         41,152
CBER9091,1461,461         3,516
CDRH308,712316,323363,033         988,068
CVM7,6727,8089,672         25,152
OC4,3964,2214,424         13,041
CTP4419242         278
MWP147369195         711
ACA67128         141
GDUFA142121         56
CFSAN241321313         875
HC9761,2241,443         3,643
Totals466,881526,990520,3170000000001,514,188
FDA ESG 2016 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS263,856362,150249,104         875,110
CDER23,67228,56630,066         82,304
CBER1,8182,2922,922         7,032
CDRH411,616421,764484,044         1,317,424
CVM11,50811,71214,508         37,728
OC8,7928,4428,848         26,082
CTP6628863         417
MWP294738390         1,422
ACA1214256         282
GDUFA284242         112
CFSAN482642626         1,750
HC1,9522,4482,886         7,286
Totals724,096839,098793,7550000000002,356,949
FDA ESG 2015 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS82,917160,010110,49693,22784,45196,088108,442121,632125,138119,059100,956118,6981,321,114
CDER11,23212,24213,69613,58612,93813,51314,17112,77713,93913,77912,94814,694159,515
CBER8197538588658079251,0729569451,0921,0701,13211,294
CDRH70,93271,92276,13385,85072,520107,745131,966192,085205,481224,725126,921112,2441,478,524
CVM3,1293,2863,5544,3084,4354,7584,9204,3435,7924,3663,9133,93450,738
OC5,3824,6484,7085,1924,6255,3074,3684,2114,3766,3745,1356,61760,943
CTP20711781141323243591037659734
MWP928310113318113295873472292111721,863
ACA41811854121201002212
GDUFA897997782,1271826740363633422,906
CFSAN4624184353422532582822962752942531933,761
HC7246307536517067081,1258047348048668619,366
Totals175,802254,160210,966204,367183,196229,649266,542337,274357,123370,861252,382258,6483,100,970
FDA ESG 2015 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS82,921160,008110,49993,22984,45196,088108,442121,632125,138119,059100,956118,6981,321,121
CDER11,23212,24213,69613,58612,93813,51314,17112,77713,93913,77912,94814,694159,515
CBER8197538588658079251,0729569451,0921,0701,13211,294
CDRH212,730215,655228,555257,598217,560323,235395,898576,255616,443674,175380,763336,7324,435,599
CVM6,2586,5727,1088,6168,8709,5169,8408,68611,5848,7327,8267,868101,476
OC5,3804,6504,7065,1944,6255,3074,3684,2114,3766,3745,1356,61760,943
CTP40142341622826464861182061521181,468
MWP928310113318113295873472292111721,863
ACA41811854121201002212
GDUFA897997782,1271826740363633422,906
CFSAN46241843534225388882962752942531933,397
HC7246307536517067081,1258047348048668619,366
Totals320,751401,250366,960380,508332,812449,759535,232725,830773,936824,780510,213487,1296,109,160
FDA ESG 2015 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS165,842320,016220,998186,458168,902192,176216,884243,264250,276238,118201,912237,3962,642,242
CDER22,46424,48427,39227,17225,87627,02628,34225,55427,87827,55825,89629,388319,030
CBER1,6381,5061,7161,7301,6141,8502,1441,9121,8902,1842,1402,26422,588
CDRH283,640287,540304,740343,464290,080430,980527,864768,340821,924898,900507,684448,9765,914,132
CVM9,3879,85810,66212,92413,30514,27414,76013,02917,37613,09811,73911,802152,214
OC10,7609,3009,41210,3889,25010,6148,7368,4228,75212,74810,27013,234121,886
CTP602135124342396961291773092281772,202
MWP1841662022663622641901746944584223443,726
ACA836236108242402004424
GDUFA1781581941564,25436413480727266845,812
CFSAN9248368706845061761765925505885063866,794
HC1,4481,2601,5061,3021,4121,4162,2501,6081,4681,6081,7321,72218,732
Totals496,533655,373577,979584,895516,008679,238801,5801,063,1041,131,0591,195,641762,595745,7779,209,782

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