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Submission Statistics

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FDA ESG 2013-2023 Total Submission Statistics
  2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Totals
AERS 876,475 1,026,314 1,321,114 1,533,378 1,698,094 2,118,827 2,160,020 2,224,503 2,287,430 2,372,414 2,149,316 19,767,885
CDER 124,232 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 286,917 273,220 2,338,753
CBER 8,412 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 646,370 182,042 1,848,113
CDRH 666,927 812,443 1,478,524 2,032,767 1,921,871 2,247,286 2,774,852 2,960,441 3,774,725 4,851,638 3,812,893 27,334,367
CVM 40,978 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 85,983 95,708 774,595
OC 65,430 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 61,314 47,926 717,960
CTP 1,237 324 734 612 23,984 19,142 3,698 10,563 5,096 4,638 1,558 71,586
ACA 207 195 212 228 218 236 271 288 233 295 314 2,697
GDUFA 2,926 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 966 1,117 19,554
CFSAN 4,220 2,756 3,761 3,619 2,661 2,421 2,261 2,160 2,540 2,240 2,454 31,093
HC 324 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 37,634 35,103 258,142
ORA                 57 58 27 142
Totals 1,791,368 2,113,020 3,100,970 3,895,669 4,055,342 4,841,844 5,428,492 5,728,006 7,258,031 8,350,467 6,601,678 53,164,887

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FDA ESG 2023 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 201,379 188,228 202,526 181,068 198,262 198,480 188,832 203,874 186,292 199,836 200,539   2,149,316
CDER 21,089 22,110 27,118 23,105 25,884 25,716 23,640 27,030 24,609 26,684 26,235   273,220
CBER 20,825 17,530 25,459 15,241 16,684 14,248 13,085 12,829 11,348 18,519 16,274   182,042
CDRH 318,486 308,034 376,811 365,283 319,972 342,198 397,276 369,797 312,375 333,257 369,404   3,812,893
CVM 8,401 6,596 8,161 7,699 8,789 8,519 9,739 11,089 8,449 8,786 9,480   95,708
OC 5,830 4,472 4,279 3,012 3,254 3,603 3,122 3,545 3,474 6,799 6,536   47,926
CTP 118 194 182 105 122 141 139 150 102 148 157   1,558
ACA 3 25 247 28 0 3 1 1 5 0 1   314
GDUFA 11 19 35 11 556 132 31 21 263 19 19   1,117
CFSAN 137 173 336 180 234 205 252 240 186 212 299   2,454
HC 2,853 2,977 3,480 2,844 3,442 3,247 3,281 3,285 2,971 3,290 3,433   35,103
ORA 1 7 5 1 0 2 4 0 1 0 6   27
Totals 579,133 550,365 648,639 598,577 577,199 596,494 639,402 631,861 550,075 597,550 632,383   6,601,678
FDA ESG 2023 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 201,379 188,228 202,526 181,068 198,262 198,480 188,832 203,874 186,292 199,836 200,539   2,149,316
CDER 42,178 44,220 54,236 46,210 51,768 51,432 47,280 54,060 49,218 53,368 52,470   546,440
CBER 41,650 35,060 50,918 30,482 33,368 28,496 26,170 25,658 22,696 37,038 32,548   364,084
CDRH 955,458 924,102 1,130,433 1,095,849 959,916 1,026,594 1,191,828 1,109,391 937,125 999,771 1,108,212   11,438,679
CVM 16,802 13,192 16,322 15,398 17,578 17,038 19,478 22,178 16,898 17,572 18,960   191,416
OC 11,660 8,944 8,558 6,024 6,508 7,206 6,244 7,090 6,948 13,598 13,072   95,852
CTP 236 388 364 210 244 282 278 300 204 296 314   3,116
ACA 6 50 494 56 0 6 2 2 10 0 2   628
GDUFA 22 38 70 22 1,112 264 62 42 526 38 38   2,234
CFSAN 137 173 336 180 234 205 252 240 186 212 299   2,454
HC 5,706 5,954 6,960 5,688 6,884 6,494 6,562 6,570 5,942 6,580 6,866   70,206
ORA 1 7 5 1 0 2 4 0 1 0 6   27
Totals 1,275,235 1,220,356 1,471,222 1,381,188 1,275,874 1,336,499 1,486,992 1,429,405 1,226,046 1,328,309 1,433,326   14,864,452

FDA ESG 2023 Monthly Total Traffic Statistics

  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 402,758 376,456 405,052 362,136 396,524 396,960 377,664 407,748 372,584 399,672 401,078   4,298,632
CDER 63,267 66,330 81,354 69,315 77,652 77,148 70,920 81,090 73,827 80,052 78,705   819,660
CBER 62,475 52,590 76,377 45,723 50,052 42,744 39,255 38,487 34,044 55,557 48,822   546,126
CDRH 1,273,944 1,232,136 1,507,244 1,461,132 1,279,888 1,368,792 1,589,104 1,479,188 1,249,500 1,333,028 1,477,616   15,251,572
CVM 25,203 19,788 24,483 23,097 26,367 25,557 29,217 33,267 25,347 26,358 28,440   287,124
OC 17,490 13,416 12,837 9,036 9,762 10,809 9,366 10,635 10,422 20,397 19,608   143,778
CTP 354 582 546 315 366 423 417 450 306 444 471   4,674
ACA 9 75 741 84 0 9 3 3 15 0 3   942
GDUFA 33 57 105 33 1,668 396 93 63 789 57 57   3,351
CFSAN 274 346 672 360 468 410 504 480 372 424 598   4,908
HC 8,559 8,931 10,440 8,532 10,326 9,741 9,843 9,855 8,913 9,870 10,299   105,309
ORA 2 14 10 2 0 4 8 0 2 0 12   54
Totals 1,854,368 1,770,721 2,119,861 1,979,765 1,853,073 1,932,993 2,126,394 2,061,266 1,776,121 1,925,859 2,065,709   21,466,130
FDA ESG 2022 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 194,547 183,842 202,537 177,211 188,958 206,503 193,707 197,179 200,937 206,910 207,807 212,276 2,372,414
CDER 21,590 24,083 26,823 23,048 24,172 24,461 22,173 24,453 25,146 22,797 24,092 24,079 286,917
CBER 73,087 75,334 68,794 56,245 53,078 57,907 61,450 55,999 62,999 30,590 28,135 22,752 646,370
CDRH 390,175 324,906 483,936 455,025 605,425 545,287 381,067 354,037 315,585 305,232 333,035 357,928 4,851,638
CVM 5,693 5,721 7,448 6,824 7,829 7,676 7,186 9,273 7,128 7,100 7,373 6,732 85,983
OC 7,106 5,766 4,372 4,780 3,889 3,867 3,070 3,406 3,486 5,655 7,195 8,722 61,314
CTP 177 267 349 207 1,615 273 376 279 312 209 352 222 4,638
ACA 3 16 240 20 8 0 2 0 2 2 1 1 295
GDUFA 15 11 48 22 669 71 17 18 24 24 19 28 966
CFSAN 156 170 218 167 246 195 204 237 152 178 130 187 2,240
HC 3,010 3,015 3,614 3,052 3,123 3,312 3,171 3,138 3,040 2,909 3,261 2,989 37,634
ORA 0 1 2 2 2 2 0 22 0 8 10 9 58
Totals 695,559 623,132 798,381 726,603 889,014 849,554 672,423 648,041 618,811 581,614 611,410 635,925 8,350,467
FDA ESG 2022 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 194,547 183,842 202,537 177,211 188,958 206,503 193,707 197,179 200,937 206,910 207,807 212,276 2,372,414
CDER 43,180 48,166 53,646 46,096 48,344 48,922 44,346 48,906 50,292 45,594 48,184 48,158 573,834
CBER 146,174 150,668 137,588 112,490 106,156 115,814 122,900 111,998 125,998 61,180 56,270 45,504 1,292,740
CDRH 1,170,525 974,718 1,451,808 1,365,075 1,816,275 1,635,861 1,143,201 1,062,111 946,755 915,696 999,105 1,073,784 14,554,914
CVM 11,386 11,442 14,896 13,648 15,658 15,352 14,372 18,546 14,256 14,200 14,746 13,464 171,966
OC 14,212 11,532 8,744 9,560 7,778 7,734 6,140 6,812 6,972 11,310 14,390 17,444 122,628
CTP 354 534 698 414 3,230 546 752 558 624 418 704 444 9,276
ACA 6 32 480 40 16 0 4 0 4 4 2 2 590
GDUFA 30 22 96 44 1,338 142 34 36 48 48 38 56 1,932
CFSAN 156 170 218 167 246 195 204 237 152 178 130 187 2,240
HC 6,020 6,030 7,228 6,104 6,246 6,624 6,342 6,276 6,080 5,818 6,522 5,978 75,268
ORA 0 1 2 2 2 2 0 22 0 8 10 9 58
Totals 1,586,590 1,387,157 1,877,941 1,730,851 2,194,247 2,037,695 1,532,002 1,452,681 1,352,118 1,261,364 1,347,908 1,417,306 19,177,860

FDA ESG 2022 Monthly Total Traffic Statistics

  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 389,094 367,684 405,074 354,422 377,916 413,006 387,414 394,358 401,874 413,820 415,614 424,552 4,744,828
CDER 64,770 72,249 80,469 69,144 72,516 73,383 66,519 73,359 75,438 68,391 72,276 72,237 860,751
CBER 219,261 226,002 206,382 168,735 159,234 173,721 184,350 167,997 188,997 91,770 84,405 68,256 1,939,110
CDRH 1,560,700 1,299,624 1,935,744 1,820,100 2,421,700 2,181,148 1,524,268 1,416,148 1,262,340 1,220,928 1,332,140 1,431,712 19,406,552
CVM 17,079 17,163 22,344 20,472 23,487 23,028 21,558 27,819 21,384 21,300 22,119 20,196 257,949
OC 21,318 17,298 13,116 14,340 11,667 11,601 9,210 10,218 10,458 16,965 21,585 26,166 183,942
CTP 531 801 1,047 621 4,845 819 1,128 837 936 627 1,056 666 13,914
ACA 9 48 720 60 24 0 6 0 6 6 3 3 885
GDUFA 45 33 144 66 2,007 213 51 54 72 72 57 84 2,898
CFSAN 312 340 436 334 492 390 408 474 304 356 260 374 4,480
HC 9,030 9,045 10,842 9,156 9,369 9,936 9,513 9,414 9,120 8,727 9,783 8,967 112,902
ORA 0 2 4 4 4 4 0 44 0 16 20 18 116
Totals 2,282,149 2,010,289 2,676,322 2,457,454 3,083,261 2,887,249 2,204,425 2,100,722 1,970,929 1,842,978 1,959,318 2,053,231 27,528,327
 

 
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