For Industry

Submission Statistics

FDA ESG 2006-2015 Total Submission Statistics
 2006200720082009201020112012201320142015Totals
AERS55,156159,562252,614300,672472,142557,917717,345876,4751,026,314 446,6574,864,854
CDER1,63911,17524,79745,51069,73993,503107,681124,232139,32250,756668,354
CBER2941,5042,5574,4835,5886,3976,9278,4129,5063,29548,963
CDRH1,5751,5274,61921,296119,087280,312462,316666,927812,443304,8462,674,948
CVM 28884385994517,93235,42940,24143,77614,277154,590
OC  18816,27548,23255,67664,28565,43068,17119,930338,187
CTP   52233486421,2373241892,968
MWP    1,1382,5302,4997378314098,144
ACA      62207195194658
GDUFA      2,7712,9263,5473439,587
CFSAN      4584,2202,7561,6579,091
HC        3245,8352,7588,917
Totals58,664174,056285,618389,100717,0941,014,6151,400,4151,791,3682,113,020845,3118,789,261
FDA ESG 2015 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS82,921160,008 110,499 93,229         446,657
CDER11,23212,242  13,696 13,586        50,756
CBER819 753858  865        3,295
CDRH70,91071,885  76,185 85,866        304,846
CVM3,1293,286  3,5544,308         14,277
OC5,380 4,650 4,7065,194         19,930
CTP20 71 17 81        189
MWP9283 101  133        409
ACA4 18 118 54        194
GDUFA89 79 97 78        343
CFSAN462 418 435 342        1,657
HC724630  753 651        2,758
Totals175,782254,123211,019204,38700000000845,311
FDA ESG 2015 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS82,921160,008 110,499 93,229         446,657
CDER11,23212,242 13,696 13,586         50,756
CBER819 753 858865         3,295
CDRH212,730215,655  228,555257,598         914,538
CVM6,2586,572  7,1088,616         28,554
OC5,3804,650 4,706 5,194        19,930
CTP40142 34 162         378
MWP92 83101 133         409
ACA4 18118  54        194
GDUFA89 7997  78        343
CFSAN462418 435 342        1,657
HC724 630 753651         2,758
Totals320,751401,250366,960380,508000000001,469,469
FDA ESG 2015 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS165,842320,016  220,998186,458         893,314
CDER22,46424,484  27,392 27,172        101,512
CBER1,6381,506  1,7161,730         6,590
CDRH283,640287,540 304,740  343,464        1,219,384
CVM9,3879,858 10,662 12,924         42,831
OC10,760 9,3009,412 10,388         39,860
CTP60213 51 243         567
MWP184166 202 266         818
ACA8 36236 108         388
GDUFA178158 194 156         686
CFSAN924836 870 684        3,314
HC1,4481,260 1,506 1,302         5,516
Totals496,533655,373577,979584,895000000002,314,780
FDA ESG 2014 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS77,48488,356118,217104,99670,06273,729103,20973,58877,41387,26869,347 82,6451,026,314
CDER10,24210,76011,29311,29311,49512,27012,38811,84011,74112,29511,036 12,669139,322
CBER630750762845792795857783830929718 8159,506
CDRH60,36469,38465,00068,37254,32760,03764,16267,55685,67079,26062,015 76,296812,443
CVM2,4842,4392,7723,3833,5333,7584,4544,2794,2304,8133,539 4,09243,776
OC6,0494,7515,1375,9985,5155,2805,1464,8184,7738,2025,445 7,05768,171
CTP3037283824182731212326 21324
MWP4557577863779377747672 62831
ACA7119645101364011 1195
GDUFA11396461772,2762601081351049062 803,547
CFSAN182147253220337239226199240181239 2932,756
HC195310364399445477781643518569570 5645,835
Totals157,825177,098204,025195,844148,879156,953191,457163,953185,614193,707153,070184,5952,113,020
FDA ESG 2014 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS77,48488,356118,217104,99670,06273,729103,20973,58877,41387,26869,34782,6451,026,314
CDER10,24210,76011,29311,29311,49512,27012,38811,84011,74112,29511,03612,669139,322
CBER6307507628457927958577838309297188159,506
CDRH181,092208,152195,000205,116162,981180,111192,486202,668257,010237,780186,045228,8882,437,329
CVM4,9684,8785,5446,7667,0667,5168,9088,5588,4609,6267,0788,18487,552
OC6,0494,7515,1375,9985,5155,2805,1464,8184,7738,2025,4457,05768,171
CTP607456764836546242465242648
MWP455757786377937774767262831
ACA7119645101364011 1195
GDUFA11396461772,2762601081351049062 803,547
CFSAN182147253220337239226198240182239 2932,756
HC195310364399445477781643518569570 5645,835
Totals280,885318,342336,825336,009261,090280,803324,262303,374361,205357,064280,665341,3003,782,006
FDA ESG 2014 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS154,968176,712236,434209,992140,124147,458206,418147,176154,826174,536138,694 165,2902,052,628
CDER20,48421,52022,58622,58622,99024,54024,77623,68023,48224,59022,072 25,338278,644
CBER1,2601,5001,5241,6901,5841,5901,7141,5661,6601,8581,436 1,63019,012
CDRH241,456277,536260,000273,488217,308240,148256,648270,224342,680317,040248,060 305,1843,249,772
CVM7,4527,3178,31610,14910,59911,27413,36212,83712,69014,43910,617 12,276131,328
OC12,0989,50210,27411,99611,03010,56010,2929,6369,54616,40410,890 14,114136,342
CTP901118411472548193636978 63972
MWP90114114156126154186154148152144 1241,662
ACA1422192902026128022 2390
GDUFA226192923544,552520216270208180124 1607,094
CFSAN364294506440674478452398480362478 5865,512
HC3906207287288909541,5621,2861,0361,1381,140 1,12811,670
Totals438,892495,440540,850531,853409,969437,756515,719467,328546,819550,770433,735525,8955,895,026

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