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Submission Statistics

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FDA ESG 2008-2018 Total Submission Statistics
 20082009201020112012201320142015201620172018Totals
AERS252,614300,672472,142557,917717,345876,4751,026,3141,321,1141,533,3781,698,0941,958,42510,929,208
CDER24,79745,51069,73993,503107,681124,232139,322159,515165,932189,141203,3561,335,542
CBER2,5574,4835,5886,3976,9278,4129,50611,29420,27852,19750,424179,861
CDRH4,61921,296119,087280,312462,316666,927812,4431,478,5242,032,7671,921,8712,075,1199,878,383
CVM8438592,08320,46237,92840,97844,60752,60164,19770,43665,455400,737
OC18816,27548,23255,67664,28565,43068,17160,94356,51771,54561,918569,180
CTP 52233486421,23732473461223,98418,78946,898
ACA    622071952122282182341,356
GDUFA    2,7712,9263,5472,9061,6441,6001,41816,812
CFSAN    4584,2202,7563,7613,6192,6612,22919,704
HC     3245,8359,36616,49723,59524,86180,478
Totals285,618389,100717,0941,014,6151,400,4151,791,3682,113,0203,100,9703,895,6694,055,3424,462,22823,458,159
FDA ESG 2018 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS193,303155,234168,917189,439187,585182,567199,129170,493160,190178,549173,019 1,958,425
CDER17,14920,81118,21017,31218,73919,15617,93119,76617,35418,56418,364 203,356
CBER3,2273,5353,4793,3483,5034,7066,0225,5824,7996,6615,562 50,424
CDRH159,841150,260167,525163,605162,229215,421162,003244,031240,069216,559193,536 2,075,119
CVM4,8815,1555,7535,4887,0356,4367,0406,1745,3246,6495,520 65,455
OC7,1374,7294,7444,8245,2624,8024,1744,7954,1237,7219,607 61,918
CTP1232741399722,0152151062694377,2936,946 18,789
ACA09170343327321 234
GDUFA441120199451617535283644 1,418
CFSAN261184221208212199248193132164207 2,229
HC1,8952,0882,2272,2742,4502,4522,4142,4921,9552,2402,374 24,861
Totals387,861342,290371,405 387,523389,978 436,118 399,144453,837434,414444,478415,180 4,462,228
FDA ESG 2018 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS193,303155,234168,917189,439187,585182,567199,129170,493160,190178,549173,019 1,958,425
CDER34,29841,62236,42034,62437,47838,31235,86239,53234,70837,12836,728 406,712
CBER3,2273,5353,4793,3483,5034,7066,0225,5824,79913,32211,124 62,647
CDRH479,523450,780502,575490,815486,687646,263486,009732,093720,207649,797580,608 6,225,357
CVM9,76210,31011,50610,97614,07012,87214,08012,34810,64813,29811,040 130,910
OC14,2749,4589,4889,64810,5249,6048,3489,5908,24615,44219,214 123,836
CTP2465482781,9444,03043021253887414,58613,892 37,578
ACA09170343327321 234
GDUFA441120199451617535283644 1,418
CFSAN261184221208212199248193132164207 2,229
HC3,7904,1764,4544,5484,9004,9044,8284,9843,9104,4804,748 49,722
Totals738,728675,867737,528745,603749,937900,021754,815975,395943,745926,804850,625 8,999,068
FDA ESG 2018 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS386,606310,468337,834378,878375,170365,134398,258340,986320,380357,098346,038 3,916,850
CDER51,44762,43354,63051,93656,21757,46853,79359,29852,06255,69255,092 610,068
CBER6,4547,0706,9586,6967,0069,41212,04411,1649,59819,98316,686 113,071
CDRH639,364601,040670,100654,420648,916861,684648,012976,124960,276866,396774,144 8,300,476
CVM14,64315,46517,25916,46421,10519,30821,12018,52215,97219,94716,560 196,365
OC21,41114,18714,23214,47215,78614,40612,52214,38512,36923,16328,821 185,754
CTP3698224172,9166,0456453188071,31121,87920,838 56,367
ACA0183406866414642 468
GDUFA882240381,89032215070567288 2,836
CFSAN522368442416424398496386264328414 4,458
HC5,6856,2646,6816,8227,3507,3567,2427,4765,8656,7207,122 74,583
Totals1,126,5891,018,1571,108,9331,133,1261,139,9151,336,1391,153,9591,429,2321,378,1591,371,2821,265,805 13,461,296
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
ACA7101493172313113218
GDUFA371122251,1181275323335049521,600
CFSAN1972112312013023442051961502611901732,661
HC1,5791,7292,1451,8782,0762,0502,1102,0411,8792,0622,1081,93823,595
Totals296,456 305,215 346,052 298,319 315,812 340,650 319,816 331,152 459,205 384,439 323,125 335,101 4,055,342
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
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
Totals887,680 906,537 1,032,585 888,555 937,036 1,034,573 952,099 987,745 1,531,530 1,171,776 995,669 1,007,342 12,333,127

 

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