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Submission Statistics Archives

FDA ESG 2023 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS201,379188,228202,526181,068198,262198,480188,832203,874186,292199,836200,539180,2902,329,606
CDER21,08922,11027,11823,10525,88425,71623,64027,03024,60926,68426,23524,829298,049
CBER20,82517,53025,45915,24116,68414,24813,08512,82911,34818,51916,27412,219194,261
CDRH318,486308,034376,811365,283319,972342,198397,276369,797312,375333,257369,404297,1514,110,044
CVM8,4016,5968,1617,6998,7898,5199,73911,0898,4498,7869,48010,792106,500
OC5,8304,4724,2793,0123,2543,6033,1223,5453,4746,7996,5368,13456,060
CTP1181941821051221411391501021481572051,763
ACA3252472803115018322
GDUFA1119351155613231212631919171,134
CFSAN1371733361802342052522401862122992192,673
HC2,8532,9773,4802,8443,4423,2473,2813,2852,9713,2903,4332,93638,039
ORA17510240106027
Totals579,133550,365648,639598,577577,199596,494639,402631,861550,075597,550632,383536,8007,138,478
FDA ESG 2023 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS201,379188,228202,526181,068198,262198,480188,832203,874186,292199,836200,539180,2902,329,606
CDER42,17844,22054,23646,21051,76851,43247,28054,06049,21853,36852,47049,658596,098
CBER41,65035,06050,91830,48233,36828,49626,17025,65822,69637,03832,54824,438388,522
CDRH955,458924,1021,130,4331,095,849959,9161,026,5941,191,8281,109,391937,125999,7711,108,212891,45312,330,132
CVM16,80213,19216,32215,39817,57817,03819,47822,17816,89817,57218,96021,584213,000
OC11,6608,9448,5586,0246,5087,2066,2447,0906,94813,59813,07216,268112,120
CTP2363883642102442822783002042963144103,526
ACA650494560622100216644
GDUFA223870221,11226462425263838342,268
CFSAN1371733361802342052522401862122992192,673
HC5,7065,9546,9605,6886,8846,4946,5626,5705,9426,5806,8665,87276,078
ORA17510240106027
Totals1,275,2351,220,3561,471,2221,381,1881,275,8741,336,4991,486,9921,429,4051,226,0461,328,3091,433,3261,190,24216,054,694
FDA ESG 2023 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS402,758376,456405,052362,136396,524396,960377,664407,748372,584399,672401,078360,5804,659,212
CDER63,26766,33081,35469,31577,65277,14870,92081,09073,82780,05278,70574,487894,147
CBER62,47552,59076,37745,72350,05242,74439,25538,48734,04455,55748,82236,657582,783
CDRH1,273,9441,232,1361,507,2441,461,1321,279,8881,368,7921,589,1041,479,1881,249,5001,333,0281,477,6161,188,60416,440,176
CVM25,20319,78824,48323,09726,36725,55729,21733,26725,34726,35828,44032,376319,500
OC17,49013,41612,8379,0369,76210,8099,36610,63510,42220,39719,60824,402168,180
CTP3545825463153664234174503064444716155,289
ACA975741840933150324966
GDUFA3357105331,66839693637895757513,402
CFSAN2743466723604684105044803724245984385,346
HC8,5598,93110,4408,53210,3269,7419,8439,8558,9139,87010,2998,808114,117
ORA21410204802012054
Totals1,854,3681,770,7212,119,8611,979,7651,853,0731,932,9932,126,3942,061,2661,776,1211,925,8592,065,7091,727,04223,193,172
FDA ESG 2022 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS194,547183,842202,537177,211188,958206,503193,707197,179200,937206,910207,807212,2762,372,414
CDER21,59024,08326,82323,04824,17224,46122,17324,45325,14622,79724,09224,079286,917
CBER73,08775,33468,79456,24553,07857,90761,45055,99962,99930,59028,13522,752646,370
CDRH390,175324,906483,936455,025605,425545,287381,067354,037315,585305,232333,035357,9284,851,638
CVM5,6935,7217,4486,8247,8297,6767,1869,2737,1287,1007,3736,73285,983
OC7,1065,7664,3724,7803,8893,8673,0703,4063,4865,6557,1958,72261,314
CTP1772673492071,6152733762793122093522224,638
ACA3162402080202211295
GDUFA1511482266971171824241928966
CFSAN1561702181672461952042371521781301872,240
HC3,0103,0153,6143,0523,1233,3123,1713,1383,0402,9093,2612,98937,634
ORA0122220220810958
Totals695,559623,132798,381726,603889,014849,554672,423648,041618,811581,614611,410635,9258,350,467
FDA ESG 2022 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS194,547183,842202,537177,211188,958206,503193,707197,179200,937206,910207,807212,2762,372,414
CDER43,18048,16653,64646,09648,34448,92244,34648,90650,29245,59448,18448,158573,834
CBER146,174150,668137,588112,490106,156115,814122,900111,998125,99861,18056,27045,5041,292,740
CDRH1,170,525974,7181,451,8081,365,0751,816,2751,635,8611,143,2011,062,111946,755915,696999,1051,073,78414,554,914
CVM11,38611,44214,89613,64815,65815,35214,37218,54614,25614,20014,74613,464171,966
OC14,21211,5328,7449,5607,7787,7346,1406,8126,97211,31014,39017,444122,628
CTP3545346984143,2305467525586244187044449,276
ACA63248040160404422590
GDUFA302296441,3381423436484838561,932
CFSAN1561702181672461952042371521781301872,240
HC6,0206,0307,2286,1046,2466,6246,3426,2766,0805,8186,5225,97875,268
ORA0122220220810958
Totals1,586,5901,387,1571,877,9411,730,8512,194,2472,037,6951,532,0021,452,6811,352,1181,261,3641,347,9081,417,30619,177,860
FDA ESG 2022 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS389,094367,684405,074354,422377,916413,006387,414394,358401,874413,820415,614424,5524,744,828
CDER64,77072,24980,46969,14472,51673,38366,51973,35975,43868,39172,27672,237860,751
CBER219,261226,002206,382168,735159,234173,721184,350167,997188,99791,77084,40568,2561,939,110
CDRH1,560,7001,299,6241,935,7441,820,1002,421,7002,181,1481,524,2681,416,1481,262,3401,220,9281,332,1401,431,71219,406,552
CVM17,07917,16322,34420,47223,48723,02821,55827,81921,38421,30022,11920,196257,949
OC21,31817,29813,11614,34011,66711,6019,21010,21810,45816,96521,58526,166183,942
CTP5318011,0476214,8458191,1288379366271,05666613,914
ACA94872060240606633885
GDUFA4533144662,0072135154727257842,898
CFSAN3123404363344923904084743043562603744,480
HC9,0309,04510,8429,1569,3699,9369,5139,4149,1208,7279,7838,967112,902
ORA0244440440162018116
Totals2,282,1492,010,2892,676,3222,457,4543,083,2612,887,2492,204,4252,100,7221,970,9291,842,9781,959,3182,053,23127,528,327

 

FDA ESG 2021 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS182,833185,634198,270183,702200,409184,877219,943193,590191,144169,348175,952201,7282,287,430
CDER19,06820,89424,71123,57723,44024,81223,75423,79524,78325,16424,23024,907283,135
CBER18,93026,67531,18346,01446,60056,09471,441137,35575,19166,98465,97074,088716,525
CDRH323,386252,371332,767288,054269,252324,867339,939381,403268,729323,952319,559350,4463,774,725
CVM5,9105,8907,7286,7527,4988,5927,7838,5267,3307,6767,9886,54388,216
OC5,6494,0045,0044,9883,8564,7944,3893,8023,5295,7925,8707,16658,843
CTP4204985233343756914844326442522461975,096
ACA6231581951171255233
GDUFA19212532263923323182525263839
CFSAN1751902112481962542132151912472311692,540
HC3,1573,2593,8693,2363,2313,6193,5893,3103,2573,3083,3443,21340,392
ORA   353159198457
Totals559,553499,459604,449556,959555,130608,696671,584752,467574,818602,759603,428668,7297,258,031
FDA ESG 2021 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS182,833185,634198,270183,702200,409184,877219,943193,590191,144169,348175,952201,7282,287,430
CDER38,13641,78849,42247,15446,88049,62447,50847,59049,56650,32848,46049,814566,270
CBER37,86053,35062,36692,02893,200112,188142,882274,710150,382133,968131,940148,1761,433,050
CDRH970,158757,113998,301864,162807,756974,6011,019,8171,144,209806,187971,856958,6771,051,33811,324,175
CVM11,82011,78015,45613,50414,99617,18415,56617,05214,66015,35215,97613,086176,432
OC11,2988,00810,0089,9767,7129,5888,7787,6047,05811,58411,74014,332117,686
CTP8409961,0466687501,3829688641,28850449239410,192
ACA124631638102214241010466
GDUFA3842506452618466463650505261,678
CFSAN1751902112481962542132151912472311692,540
HC6,3146,5187,7386,4726,4627,2387,1786,6206,5146,6166,6886,42680,784
ORA   353159198457
Totals1,259,4841,065,4651,339,5261,218,0191,178,9021,357,1251,462,9361,692,5231,227,0291,359,8661,350,2241,486,00316,000,760
FDA ESG 2021 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS365,666371,268396,540367,404400,818369,754439,886387,180382,288338,696351,904403,4564,574,860
CDER57,20462,68274,13370,73170,32074,43671,26271,38574,34975,49272,69074,721849,405
CBER56,79080,02593,549138,042139,800168,282214,323412,065225,573200,952197,910222,2642,149,575
CDRH1,293,5441,009,4841,331,0681,152,2161,077,0081,299,4681,359,7561,525,6121,074,9161,295,8081,278,2361,401,78415,098,900
CVM17,73017,67023,18420,25622,49425,77623,34925,57821,99023,02823,96419,629264,648
OC16,94712,01215,01214,96411,56814,38213,16711,40610,58717,37617,61021,498176,529
CTP1,2601,4941,5691,0021,1252,0731,4521,2961,93275673859115,288
ACA186947457153321361515699
GDUFA5763759678927699695475757892,517
CFSAN3503804224963925084264303824944623385,080
HC9,4719,77711,6079,7089,69310,85710,7679,9309,7719,92410,0329,639121,176
ORA   61063018218168114
Totals1,819,0371,564,9241,943,9751,774,9781,734,0321,965,8212,134,5202,444,9901,801,8471,962,6251,953,6522,154,73223,258,791
FDA ESG 2020 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS204,918180,498186,259184,920173,310182,363194,758172,313182,097185,758180,080197,2292,224,503
CDER19,77019,39721,77422,02320,61622,15822,67620,60322,39723,36821,14123,361259,284
CBER6,3255,4776,8886,4224,9855,0016,0665,4865,7206,5066,5909,07974,545
CDRH261,384233,864250,764225,618192,993236,836250,483216,666253,108265,993279,854292,8782,960,441
CVM6,4476,0877,0196,0326,7258,8178,5297,2357,9717,7686,7727,03586,437
OC8,5114,6875,0835,8606,2985,4605,0014,5364,3137,6586,4419,52173,369
CTP2684664288734624696901,2234,38767731430610,563
ACA21720139321631202288
GDUFA24141024924103401981334361,249
CFSAN1481741441161831762312761701811821792,160
HC2,2382,4242,8172,5532,6552,9643,1302,7443,1053,3843,4733,68035,167
Totals510,035453,105481,387454,480409,154464,349491,605431,107483,279501,318504,881543,3065,728,006
FDA ESG 2020 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS204,918180,498186,259184,920173,310182,363194,758172,313182,097185,758180,080197,2292,224,503
CDER39,54038,79443,54844,04641,23244,31645,35241,20644,79446,73642,28246,722518,568
CBER12,65010,95413,77612,8449,97010,00212,13210,97211,44013,01213,18018,158149,090
CDRH784,152701,592752,292676,854578,979710,508751,449649,998759,324797,979839,562878,6348,881,323
CVM12,89412,17414,03812,06413,45017,63417,05814,47015,94215,53613,54414,070172,874
OC17,0229,37410,16611,72012,59610,92010,0029,0728,62615,31612,88219,042146,738
CTP5369328561,7469249381,3802,4468,7741,35462861221,126
ACA434402786421262404576
GDUFA482820481,8482068038162668722,498
CFSAN1481741441161831762312761701811821792,160
HC4,4764,8485,6345,1065,3105,9286,2605,4886,2106,7686,9467,36070,334
Totals1,076,388959,4021,027,135949,542837,808982,9951,038,704906,2911,037,3991,082,6901,109,3541,182,08212,189,790
FDA ESG 2020 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS409,836360,996372,518369,840346,620364,726389,516344,626364,194371,516360,160394,4584,449,006
CDER59,31058,19165,32266,06961,84866,47468,02861,80967,19170,10463,42370,083777,852
CBER18,97516,43120,66419,26614,95515,00318,19816,45817,16019,51819,77027,237223,635
CDRH1,045,536935,4561,003,056902,472771,972947,3441,001,932866,6641,012,4321,063,9721,119,4161,171,51211,841,764
CVM19,34118,26121,05718,09620,17526,45125,58721,70523,91323,30420,31621,105259,311
OC25,53314,06115,24917,58018,89416,38015,00313,60812,93922,97419,32328,563220,107
CTP8041,3981,2842,6191,3861,4072,0703,66913,1612,03194291831,689
ACA6516031179631893606864
GDUFA724230722,7723091205724391021083,747
CFSAN2963482882323663524625523403623643584,320
HC6,7147,2728,4517,6597,9658,8929,3908,2329,31510,15210,41911,040105,501
Totals1,586,4231,412,5071,508,5221,404,0221,246,9621,447,3441,530,3091,337,3981,520,6781,584,0081,614,2351,725,38817,917,796
FDA ESG 2019 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS181,081184,222173,881184,934180,281173,129227,099175,299170,006166,754160,326183,0082,160,020
CDER19,24018,24317,90920,25221,02419,13220,34720,36919,50021,44119,03120,096236,584
CBER5,8205,0415,5265,1896,0155,2156,7826,5005,5485,9796,5146,77170,900
CDRH236,293198,378227,468210,646196,542191,825209,244239,956330,931247,397242,205 243,9672,774,852
CVM5,7045,3055,4365,8336,6626,5117,3516,6536,3136,8616,0946,02774,750
OC6,2834,9876,0384,4424,3054,2263,7284,3185,8059,16810,01313,236 76,549
CTP2351822303173124832763964302842023513,698
ACA8211843474622111271
GDUFA231949238551093519453049491,305
CFSAN2042002011712621912011381401662131742,261
HC2,3762,0592,2522,2562,3522,2732,7212,3082,0322,2822,2372,15427,302
Totals457,267418,657439,174434,097418,617403,098477,790455,958540,752460,363446,885475,8345,428,492
FDA ESG 2019 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS181,081184,222173,881184,934180,281173,129227,099175,299170,006166,754160,326183,0082,160,020
CDER38,48036,48635,81840,50442,04838,26440,69440,73839,00042,88238,06240,192473,168
CBER11,64010,08211,05210,37812,03010,43013,56413,00011,09611,95813,02813,542141,800
CDRH708,879595,134682,404631,938589,626575,475627,732719,868992,793742,191726,615731,9018,324,556
CVM11,40810,61010,87211,66613,32413,02214,70213,30612,62613,72212,18812,054149,500
OC6,2839,97412,0768,8848,6108,4527,4568,63611,61018,33620,02626,472153,098
CTP4703644606346249665527928605684047027,396
ACA1642368681481244222542
GDUFA463898461,7102187038906098982,610
CFSAN2042002011712621912011381401662131742,261
HC4,7524,1184,5044,5124,7044,5465,4424,6164,0644,5644,4744,30854,604
Totals969,542851,270931,734893,735853,233824,701937,524976,4351,242,2891,001,203975,4361,012,45311,469,555
FDA ESG 2019 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS362,162368,444347,762369,868360,562346,258454,198350,598340,012333,508320,652366,0164,320,040
CDER57,72054,72953,72760,75663,07257,39661,04161,10758,50064,32357,09360,288709,752
CBER17,46015,12316,57815,56718,04515,64520,34619,50016,64417,93719,54220,313212,700
CDRH945,172793,512909,872842,584786,168767,300836,976959,8241,323,724989,588968,820975,86811,099,408
CVM17,11215,91516,30817,49919,98619,53322,05319,95918,93920,58318,28218,081224,250
OC18,84914,96118,11413,32612,91512,67811,18412,95417,41527,50430,03939,708229,647
CTP7055466909519361,4498281,1881,2908526061,05311,094
ACA246355210221121866333813
GDUFA6957147692,56532710557135901471473,915
CFSAN4084004023425243824022762803324263484,522
HC7,1286,1776,7566,7687,0566,8198,1636,9246,0966,8466,7116,46281,906
Totals1,426,8091,269,9271,370,9081,327,8321,271,8501,227,7991,415,3141,432,3931,783,0411,461,5661,422,3211,488,28716,898,047
FDA ESG 2018 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS193,303155,234168,917189,439187,585182,567199,129170,493160,190178,549173,019160,4022,118,827
CDER17,14920,81118,21017,31218,73919,15617,93119,76617,35418,56418,36418,115221,471
CBER3,2273,5353,4793,3483,5034,7066,0225,5824,7996,6615,5625,62056,044
CDRH159,841150,260167,525163,605162,229215,421162,003244,031240,069216,559193,536176,1672,247,286
CVM4,8815,1555,7535,4887,0356,4367,0406,1745,3246,6495,5205,22770,682
OC7,1374,7294,7444,8245,2624,8024,1744,7954,1237,7219,60715,43577,353
CTP1232741399722,0152151062694377,2936,94635319,142
MWP0000000000000
ACA091703433273212236
GDUFA441120199451617535283644371,455
CFSAN2611842212082121992481931321642071922,421
HC1,8952,0882,2272,2742,4502,4522,4142,4921,9552,2402,3742,06626,927
Totals387,861342,290371,405387,523389,978436,118399,144453,837434,414444,478415,180379,6164,841,844
FDA ESG 2018 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS193,303155,234168,917189,439187,585182,567199,129170,493160,190178,549173,019160,4022,118,827
CDER34,29841,62236,42034,62437,47838,31235,86239,53234,70837,12836,72836,230442,942
CBER3,2273,5353,4793,3483,5034,7066,0225,5824,79913,32211,12411,24073,887
CDRH479,523450,780502,575490,815486,687646,263486,009732,093720,207649,797580,608516,5016,741,858
CVM9,76210,31011,50610,97614,07012,87214,08012,34810,64813,29811,04010,454141,364
OC14,2749,4589,4889,64810,5249,6048,3489,5908,24615,44219,21415,435139,271
CTP2465482781,9444,03043021253887414,58613,89270638,284
MWP0000000000000
ACA091703433273214238
GDUFA441120199451617535283644741,492
CFSAN2611842212082121992481931321642071922,421
HC3,7904,1764,4544,5484,9004,9044,8284,9843,9104,4804,7484,13253,854
Totals738,728675,867737,528745,603749,937900,021754,815975,395 943,745926,804850,625755,3709,754,438
FDA ESG 2018 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS386,606310,468337,834378,878375,170365,134398,258340,986320,380357,098346,038320,8044,237,654
CDER51,44762,43354,63051,93656,21757,46853,79359,29852,06255,69255,09254,345664,413
CBER6,4547,0706,9586,6967,0069,41212,04411,1649,59819,98316,68616,860129,931
CDRH639,364601,040670,100654,420648,916861,684648,012976,124960,276866,396774,144688,6688,989,144
CVM14,64315,46517,25916,46421,10519,30821,12018,52215,97219,94716,56015,681212,046
OC21,41114,18714,23214,47215,78614,40612,52214,38512,36923,16328,82130,870216,624
CTP3698224172,9166,0456453188071,31121,87920,8381,05957,426
MWP0000000000000
ACA01834068664146426474
GDUFA882240381,890322150705672881112,947
CFSAN5223684424164243984963862643284143844,842
5,8655,6856,2646,6816,8227,3507,3567,2427,4765,8656,7207,1226,19880,781
Totals1,126,5891,018,1571,108,9331,133,1261,139,9151,336,1391,153,9591,429,2321,378,1591,371,2821,265,8051,134,98614,596,282
FDA ESG 2017 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS132,260139,651148,193133,979140,483143,564145,394147,858134,031161,900126,763144,0181,698,094
CDER13,89614,31516,69014,39216,46817,33414,56316,97816,23816,02616,19816,043189,141
CBER3,9074,2514,4764,3816,0954,2654,1865,0864,6254,4903,5072,92852,197
CDRH134,720135,026147,500132,215137,605160,925142,492147,453292,757185,161156,804149,2131,921,871
CVM4,8834,2545,7867,0006,7166,7346,3606,7935,4796,2255,5834,62370,436
OC4,8154,5784,3234,0524,7094,8854,0644,3163,7046,7589,43415,90771,545
CTP1551,17916,5371652334203864073061,5052,48820323,984
MWP0000000000000
ACA7101493172313113218
GDUFA371122251,1181275323335049521,600
CFSAN1972112312013023442051961502611901732,661
HC1,5791,7292,1451,8782,0762,0502,1102,0411,8792,0622,1081,93823,595
Totals296,456305,215346,052298,319315,812340,650319,816331,152459,205384,439323,125335,1014,055,342
FDA ESG 2017 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS132,260139,651148,193133,979140,483143,564145,394147,858134,031161,900126,763144,0181,698,094
CDER27,79228,63033,38028,78432,93634,66829,12633,95632,47632,05232,39632,086378,282
CBER3,9074,2514,4764,3816,0954,2654,1865,0864,6254,4903,5072,92852,197
CDRH404,160405,078442,500396,645412,815482,775427,476442,359878,271555,483470,412447,6395,765,613
CVM9,7668,50811,57214,00013,43213,46812,72013,58610,95812,45011,1669,246140,872
OC9,6309,1568,6468,1049,4189,7708,1288,6327,40813,51618,86831,814143,090
CTP3102,35833,0743304668407728146123,0104,97640647,968
MWP0000000000000
ACA7101493172313113218
GDUFA371122251,1181275323335049521,600
CFSAN1972112312013023442051961502611901732,661
HC3,1583,4584,2903,7564,1524,1004,2204,0823,7584,1244,2163,87647,190
Totals591,224601,322686,533590,236621,224693,923632,283656,5931,072,325787,337672,544672,2418,277,785
FDA ESG 2017 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS264,520279,302296,386267,958280,966287,128290,788295,716268,062323,800253,526288,0363,396,188
CDER41,68842,94550,07043,17649,40452,00243,68950,93448,71448,07848,59448,129567,423
CBER7,8148,5028,9528,76212,1908,5308,37210,1729,2508,9807,0145,856104,394
CDRH538,880540,104590,000528,860550,420643,700569,968589,8121,171,028740,644627,216596,8527,687,484
CVM14,64912,76217,35821,00020,14820,20219,08020,37916,43718,67516,74913,869211,308
OC14,44513,73412,96912,15614,12714,65512,19212,94811,11220,27428,30247,721214,635
CTP4653,53749,6114956991,2601,1581,2219184,5157,46460971,952
MWP0000000000000
ACA142029862144626226436
GDUFA742244502,2362541064666100981043,200
CFSAN3944224624026046884103923005223803465,322
HC4,7375,1876,4355,6346,2286,1506,3306,1235,6376,1866,3245,81470,785
Totals887,680906,5371,032,585888,555937,0361,034,573952,099987,7451,531,5301,171,776995,6691,007,34212,333,127
FDA ESG 2016 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS131,928181,075124,552118,835123,781123,487119,245125,029120,565124,496118,465121,9201,533,378
CDER11,83614,28315,03314,04614,08814,53712,25613,96414,01813,24613,70514,920165,932
CBER9091,1461,4611,4591,3211,4181,5101,6431,7061,7701,9024,03320,278
CDRH102,904105,441121,011144,773129,037146,535179,350230,948359,327235,412135,945142,0842,032,767
CVM3,8363,9044,8365,4356,4986,0625,1636,5425,5445,5315,5854,46863,404
OC4,3964,2214,4243,9204,2504,4524,0154,3624,3526,4555,4136,25756,517
CTP2296212240672664453536138612
MWP1473691958200000000793
ACA6712860142311330228
GDUFA142121361,1151995936403537311,644
CFSAN2413213133074705173272021812052502853,619
HC9761,2241,4431,3361,2441,4651,3891,4071,3931,3551,5961,66916,497
Totals257,215312,108273,438290,311281,858298,741323,343384,198507,172388,543282,937295,8053,895,669
FDA ESG 2016 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS131,928181,075124,552118,835123,781123,487119,245125,029120,565124,496118,465121,9201,533,378
CDER11,83614,28315,03314,04614,08829,07424,51227,92828,03626,49227,41029,840262,578
CBER9091,1461,4611,4591,3211,4181,5101,6431,7061,7701,9024,03320,278
CDRH308,712316,323363,033434,319387,111439,605538,050692,8441,077,981706,236407,835426,2526,098,301
CVM7,6727,8089,67210,87012,99612,12410,32613,08411,08811,06211,1708,936126,808
OC8,7928,4428,8487,8408,5008,9048,0308,7248,70412,91010,82612,514113,034
CTP44192424480134521289070722761,224
MWP1473691958200000000793
ACA6712860142311330228
GDUFA142121361,1151995936403537311,644
CFSAN2413213133074705173272021812052502853,619
HC9761,2241,4431,3361,2441,4652,7782,8142,7862,7103,1923,33825,306
Totals471,277531,211524,741589,234550,720616,929704,892872,4331,251,178885,989581,162607,4258,187,191
FDA ESG 2016 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS263,856362,150249,104237,670247,562246,974238,490250,058241,130248,992236,930243,8403,066,756
CDER23,67228,56630,06628,09228,17643,61136,76841,89242,05439,73841,11544,760428,510
CBER1,8182,2922,9222,9182,6422,8363,0203,2863,4123,5403,8048,06640,556
CDRH411,616421,764484,044579,092516,148586,140717,400923,7921,437,308941,648543,780568,3368,131,068
CVM11,50811,71214,50816,30519,49418,18615,48919,62616,63216,59316,75513,404190,212
OC13,18812,66313,27211,76012,75013,35612,04513,08613,05619,36516,23918,771169,551
CTP662886366120201781921351051084141,836
MWP294738390164000000001,586
ACA1214256120284622660456
GDUFA284242722,23039811872807074623,288
CFSAN4826426266149401,0346544043624105005707,238
HC1,9522,4482,8862,6722,4882,9304,1674,2214,1794,0654,7885,00741,803
Totals728,492843,319798,179879,545832,578915,6701,028,2351,256,6311,758,3501,274,532864,099903,23012,082,860
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
FDA ESG 2014 Monthly Submission 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
CDRH60,36469,38465,00068,37254,32760,03764,16267,55685,67079,26062,01576,296812,443
CVM2,4842,4392,7723,3833,5333,7584,4544,2794,2304,8133,5394,09243,776
OC6,0494,7515,1375,9985,5155,2805,1464,8184,7738,2025,4457,05768,171
CTP303728382418273121232621324
MWP455757786377937774767226831
ACA71196451013640111195
GDUFA11396461772,2762601081351049062803,547
CFSAN1821472532203372392261992401812392932,756
HC1953103643994454777816435185695705645,835
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
ACA71196451013640111195
GDUFA11396461772,2762601081351049062803,547
CFSAN1821472532203372392261982401822392932,756
HC1953103643994454777816435185695705645,835
Totals280,885318,342336,825336,009261,090280,803324,262303,374361,205357,064280,665341,3003,782,006
 
FDA ESG 2014 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS154,968176,712236,434209,992140,124147,458206,418147,176154,826174,536138,694165,2902,052,628
CDER20,48421,52022,58622,58622,99024,54024,77623,68023,48224,59022,07225,338278,644
CBER1,2601,5001,5241,6901,5841,5901,7141,5661,6601,8581,4361,63019,012
CDRH241,456277,536260,000273,488217,308240,148256,648270,224342,680317,040248,060305,1843,249,772
CVM7,4527,3178,31610,14910,59911,27413,36212,83712,69014,43910,61712,276131,328
OC12,0989,50210,27411,99611,03010,56010,2929,6369,54616,40410,89014,114136,342
CTP90111841147254819363697863972
MWP901141141561261541861541481521441241,662
ACA14221929020261280222390
GDUFA226192923544,5525202162702081801241607,094
CFSAN3642945064406744784523984803624785865,512
HC3906207287288909541,5621,2861,0361,1381,1401,12811,670
Totals438,892495,440540,850531,853409,969437,756515,719467,328546,819550,770433,735525,8955,895,026
 
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
CFSAN3202322342371801291431782111,6213131634,220
HC          154170324
Totals158,041125,931124,219147,644140,456146,569151,263154,621139,644204,229145,388153,1041,791,368
 
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
CFSAN3202322342371801291431782111,6213131634,220
HC          154170324
Totals250,938220,563211,347271,154248,476273,625281,149288,240249,909345,058254,403272,5013,167,622
 
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>64046404743602582863564223,2426263267,454
HC          308340648
Totals408,979346,494335,098418,798388,932420,194432,412442,861389,553549,287399,791425,6054,958,004
 
FDA ESG 2012 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS68,10252,38152,62651,15157,52054,13753,45366,62661,27777,90965,46556,698717,345
CDER7,4558,0549,4658,5889,2508,8158,32410,3669,0798,97110,2459,069107,681
CBER4705185955946075636366215345985736186,927
CDRH36,66938,84353,23641,05635,87134,65738,24837,72733,20840,84035,54536,416462,316
CVM3,3764,0482,6592,6332,9052,8543,1263,6902,3452,6322,6312,53035,429
OC6,6494,8045,1015,0235,0935,1024,6875,9064,7906,2065,4505,47464,285
CTP797337131452564102273587642
MWP272344616287>58656445842>5675632,499
ACA        32216362
GDUFA        366331409932,771
CFSAN          260198458
Totals123,072108,999124,301109,369111,963106,229108,543125,058111,445137,893121,694111,8491,400,415
 
FDA ESG 2011 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS47,16037,28247,73942,66545,93949,65440,09454,15440,69550,21756,38745,931557,917
CDER6,3207,2488,2137,6498,0088,2517,6868,3647,9997,8587,9028,00593,503
CBER3964766054665365745346115335305625746,937
CDRH20,19413,37417,27521,68019,56720,07527,47824,50126,52232,54629,42727,673280,312
CVM2804445625167146745652,9203,4983,2402,8271,69217,932
OC5,7584,0414,6384,3804,6455,7264,6514,6163,9743,8614,4514,93555,676
CTP2612246102473171813665348
MWP1601711831641901651122001912663543742,530
Totals80,29463,04879,23977,52679,60985,14381,12795,36983,42998,536102,04689,2491,014,615
 
FDA ESG 2010 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS28,80128,88931,71327,60127,30538,69767,08547,58742,62235,51040,00757,045472,142
CDER4,1714,6605,7985,5815,6396,1365,6966,1955,9806,2796,4857,11969,739
CBER3614275354573995555024774494764415095,588
CDRH3,4656,1086,9047,1536,2178,18313,59012,09710,62018,09611,90514,749119,087
CVM78106739359906777516774110945
OC3,9043,9064,1143,6493,7455,7674,3014,4993,5193,4153,4574,76648,232
CTP1236143612017209643223
MWP    1061571061761301191142301,138
Totals40,06143,30949,14344,54843,47359,64691,36771,12563,39163,97162,48984,571717,094
 
FDA ESG 2009 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS19,26121,03126,58122,15222,56926,24024,22429,09730,46725,24025,48028,330300,672
CDER2,2682,9983,2353,4083,4933,6923,9894,0754,1824,7584,5524,86045,510
CBER2572613413382903623633523654795175584,483
CDRH7008121,6421,5541,3611,3451,6941,3392,4482,5293,2992,57321,296
CVM60731031037070966858465557859
OC637010296858409691,4161,8522,6402,9715,17116,275
CTP           55
Totals22,60925,24532,00427,65127,86832,54931,33536,34739,37235,69236,87441,554389,100
 
FDA ESG 2008 Monthly Submission Statistics
 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
 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
 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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