For Industry

Submission Statistics

FDA ESG 2006-2014 Total Submission Statistics
 200620072008200920102011201220132014Totals
AERS55,156159,562252,614300,672472,142557,917717,345876,4751,026,314 4,418,197
CDER1,63911,17524,79745,51069,73993,503107,681124,232139,322 617,598
CBER2941,5042,5574,4835,5886,3976,9278,4129,506 45,668
CDRH1,5751,5274,61921,296119,087280,312462,316666,927812,443 2,370,102
CVM 28884385994517,93235,42940,24143,776 140,313
OC  18816,27548,23255,67664,28565,43068,171 318,257
CTP   52233486421,237324 2,779
MWP    1,1382,5302,499737831 7,735
ACA      62207195 464
GDUFA      2,7712,9263,547 9,244
CFSAN      4583,564508 4,530
HC        3245,835 6,159
Totals58,664174,056285,618389,100717,0941,014,6151,400,4151,790,7122,110,7727,941,046
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
CFSAN02253873445149595551 61508
HC195310364399445477781643518569570 5645,835
Totals157,643176,953203,797195,662148,615156,758191,282163,803185,443193,581152,882184,3632,110,772
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
CFSAN02253873445149595551 61508
HC195310364399445477781643518569570 5645,835
Totals280,885318,197336,597335,827260,826280,608324,087303,225361,024356,937280,477341,0683,779,758
FDA ESG 2014 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS154,968176,712236,434209,992140,124147,458206,418147,176154,876174,536138,694 165,2902,052,628
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
CFSAN0450761468810298118110102 1221,016
HC3906207287988909541,5621,2861,0361,1381,140 1,12811,670
Totals438,528495,150540,394531,489409,441437,366515,369467,028546,457550,518433,359525,4315,890,530
FDA ESG 2013 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS93,36561,63863,67166,88265,28464,80768,03969,49567,313111,46972,20672,306876,475
CDER9,0959,65710,19910,91411,21210,32210,63510,2919,80711,2219,94410,935124,232
CBER6195666546807366677917647808116586868,412
CDRH45,04445,46342,22059,46551,91461,17363,19065,24953,31668,70452,94258,247666,927
CVM2,4033,6082,6124,3963,6784,3963,2543,0123,5073,4013,1252,84940,241
OC6,9314,5324,4004,7855,1544,6994,9355,3774,4056,8085,8607,54465,430
CTP203493892257157126109126206541,237
MWP615444555682575756757961737
ACA09476733112046163207
GDUFA0123100711,95212673851179895862,926
CFSAN32023202371801291431782111,62131303,564
HC          154170324
Totals158,041125,931123,985147,644140,456146,569151,263154,621139,644204,229145,388152,9411,790,712
FDA ESG 2013 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS93,36561,63863,67166,88265,28464,80768,03969,49567,313111,46972,20672,306876,475
CDER9,0959,65710,19910,91411,21210,32210,63510,2919,80711,2219,94410,935124,232
CBER6195666546807366677917647808116586868,412
CDRH135,132136,389126,660178,395155,742183,519189,570195,747159,948206,112158,826174,7412,000,781
CVM4,8067,2165,2248,7927,3568,7926,5086,0247,0146,8026,2505,69880,482
OC6,9314,5324,4004,7855,1544,6994,9355,3774,4056,8085,8607,54465,430
CTP60914711427677147137821825240121083,396
MWP615444555682575756757961737
ACA09476733112046163207
GDUFA0123100711,95212673851179895862,926
CFSAN32023202371801291431782111,62131303,564
HC          154170324
Totals250,938220,563211,113271,154248,476273,625281,149288,240249,909345,058254,403272,3383,166,966
FDA ESG 2013 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS186,730123,276127,342133,764130,568129,614136,078138,990134,626222,938144,412144,6121,752,950
CDER18,19019,31420,39821,82822,42420,64421,27020,58219,61422,44219,88821,870248,464
CBER1,2361,1321,3081,3601,4721,3341,5821,5281,5601,6221,3161,37216,824
CDRH180,176181,852168,880237,860207,656244,692252,760260,996213,264274,816211,768232,9882,667,708
CVM7,20910,8247,83613,18811,03413,1889,7629,03610,52110,2039,3758,547120,723
OC13,8629,0648,8009,57010,3089,3989,87010,7548,81013,61611,72015,088130,860
CTP8121961523681,02862850432737860181624,633
MWP122108881101121641141141121501581221,474
ACA018941346622408122126414
GDUFA02462001423,9042521461702341961901725,852
CFSAN>64046404743602582863564223,24262607,128
HC          308340648
Totals408,979346,494335,098418,798388,932420,194432,412442,861389,553549,287399,791425,2794,957,678

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