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Submission Statistics

FDA ESG 2014-2024 Total Submission Statistics
 20142015201620172018201920202021202220232024Totals
AERS1,026,3141,321,1141,533,3781,698,0942,118,8272,160,0202,224,5032,287,4302,372,4142,329,6062,217,58321,289,283
CDER139,322159,515165,932189,141221,471236,584259,284283,135286,917298,049319,5212,558,871
CBER9,50611,29420,27852,19756,04470,90074,545716,525646,370194,261148,1842,000,104
CDRH812,4431,478,5242,032,7671,921,8712,247,2862,774,8522,960,4413,774,7254,851,6384,110,0444,631,82131,596,412
CVM44,60752,60164,19770,43670,68274,75086,43788,21685,983106,500135,589879,998
OC68,17160,94356,51771,54577,35376,54973,36958,84361,31456,06058,265718,929
CTP32473461223,98419,1423,69810,5635,0964,6381,7633,17173,725
ACA1952122282182362712882332953222612,759
GDUFA3,5472,9061,6441,6001,4551,3051,2498399661,1341,00517,650
CFSAN *2,7563,7613,6192,6612,4212,2612,1602,5402,2402,6732,18429,276
HFP *          2,9242,924
HC5,8359,36616,49723,59526,92727,30235,16740,39237,63438,03937,074297,828
ORA *       57582714156
OII *        0000
Totals2,113,0203,100,9703,895,6694,055,3424,841,8445,428,4925,728,0067,258,0318,350,4677,138,4787,557,59659,467,915

Note: * On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency.  

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FDA ESG 2024 Monthly Submission Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS185,398193,376173,136183,932186,020168,632207,012177,222181,400214,109172,058175,2882,217,583
CDER25,26426,28826,13427,12327,59825,62228,32526,17227,27128,62025,91025,194319,521
CBER18,74114,08212,10911,31221,6598,55110,59510,0899,24712,30410,4209,075148,184
CDRH340,896363,556317,844348,358432,142381,393426,715447,484396,950394,566409,979371,9384,631,821
CVM12,08510,60710,77911,93712,46611,53311,90310,43012,40711,6089,8889,946135,589
OC6,1173,2093,4334,0924,6743,7904,4394,1283,7656,8105,5038,30558,265
CTP1941573224232272813182822252172163093,171
ACA538142191145331102261
GDUFA44450524602631617451081,005
CFSAN275238219204285236258207262   2,184
HFP         1,0201,0318732,924
HC3,1113,0602,9373,1873,2462,9383,4372,8562,8713,2373,1083,08637,074
ORA2010100100   14
OII         0000
Totals592,092614,615547,069590,638688,852603,040693,271678,919634,416672,537638,123604,0247,557,596

 

 

FDA ESG 2024 Monthly Acknowledgement Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS185,398193,376173,136183,932186,020168,632207,012177,222181,400214,109172,058175,2882,217,583
CDER50,52852,57652,26854,24655,19651,24456,65052,34454,54257,24051,82050,388639,042
CBER37,48228,16424,21822,62443,31817,10221,19020,17818,49424,60820,84018,150296,368
CDRH1,022,6881,090,668953,5321,045,0741,296,4261,144,1791,280,1451,342,4521,190,8501,183,6981,229,9371,115,81413,895,463
CVM24,17021,21421,55823,87424,93223,06623,80620,86024,81423,21619,77619,892271,178
OC12,2346,4186,8668,1849,3487,5808,8788,2567,53013,62011,00616,610116,530
CTP3883146448464545626365644504344326186,342
ACA10762843822810662204522
GDUFA8881001,04812052632349020162,010
CFSAN275238219204285236258207262   2,184
HFP         1,0201,0318732,924
HC6,2226,1205,8746,3746,4925,8766,8745,7125,7426,4746,2166,17274,148
ORA2010100100   14
OII         0000
Totals1,339,4051,399,1721,238,6171,345,4971,623,5411,418,6051,605,9861,627,8931,484,1201,524,5111,513,1361,403,82517,524,308

 

FDA ESG 2024 Monthly Total Traffic Statistics
 JanFebMarAprMayJunJulAugSeptOctNovDecTotals
AERS370,796386,752346,272367,864372,040337,264414,024354,444362,800428,218344,116350,5764,435,166
CDER75,79278,86478,40281,36982,79476,86684,97578,51681,81385,86077,73075,582958,563
CBER56,22342,24636,32733,93664,97725,65331,78530,26727,74136,91231,26027,225444,552
CDRH1,363,5841,454,2241,271,3761,393,4321,728,5681,525,5721,706,8601,789,9361,587,8001,578,2641,639,9161,487,75218,527,284
CVM36,25531,82132,33735,81137,39834,59935,70931,29037,22134,82429,66429,838406,767
OC18,3519,62710,29912,27614,02211,37013,31712,38411,29520,43016,50924,915174,795
CTP5824719661,2696818439548466756516489279,513
ACA1511442657331215993306783
GDUFA1212121501,572180789485113530243,015
CFSAN550476438408570472516414524   4,368
HFP         2,0402,0621,7465,848
HC9,3339,1808,8119,5619,7388,81410,3118,5688,6139,7119,3249,258111,222
ORA4020200200   28
OII         0000
Totals1,931,4972,013,7871,785,6861,936,1352,312,3932,021,6452,299,2572,306,8122,118,5362,197,0482,151,2592,007,84925,081,904

 

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
 

 

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