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Submission Statistics

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FDA ESG 2012-2022 Total Submission Statistics
  2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Totals
AERS 717,345 876,475 1,026,314 1,321,114 1,533,378 1,698,094 2,118,827 2,160,020 2,224,503 2,287,430 580,926 16,544,426
CDER 107,681 124,232 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 72,496 1,958,793
CBER 6,927 8,412 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 217,215 1,243,843
CDRH 462,316 666,927 812,443 1,478,524 2,032,767 1,921,871 2,247,286 2,774,852 2,960,441 3,774,725 1,199,017 20,331,169
CVM 37,928 40,978 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 18,862 649,694
OC 64,285 65,430 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 17,244 690,249
CTP 642 1,237 324 734 612 23,984 19,142 3,698 10,563 5,096 793 66,825
ACA 62 207 195 212 228 218 236 271 288 233 259 2,409
GDUFA 2,771 2,926 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 74 20,316
CFSAN 458 4,220 2,756 3,761 3,619 2,661 2,421 2,261 2,160 2,540 544 27,401
HC   324 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 9,639 195,044
ORA                   57 3 60
Totals 1,400,415 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 2,117,072 41,730,229
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                   580,926
CDER 21,590 24,083 26,823                   72,496
CBER 73,087 75,334 68,794                   217,215
CDRH 390,175 324,906 483,936                   1,199,017
CVM 5,693 5,721 7,448                   18,862
OC 7,106 5,766 4,372                   17,244
CTP 177 267 349                   793
ACA 3 16 240                   259
GDUFA 15 11 48                   74
CFSAN 156 170 218                   544
HC 3,010 3,015 3,614                   9,639
ORA 0 1 2                   3
Totals 695,559 623,132 798,381                   2,117,072
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                   580,926
CDER 43,180 48,166 53,646                   144,992
CBER 146,174 150,668 137,588                   434,430
CDRH 1,170,525 974,718 1,451,808                   3,597,051
CVM 11,386 11,442 14,896                   37,724
OC 14,212 11,532 8,744                   34,488
CTP 354 534 698                   1,586
ACA 6 32 480                   518
GDUFA 30 22 96                   148
CFSAN 156 170 218                   544
HC 6,020 6,030 7,228                   19,278
ORA 0 1 2                   3
Totals 1,586,590 1,387,157 1,877,941                   4,851,688

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                   1,161,852
CDER 64,770 72,249 80,469                   217,488
CBER 219,261 226,002 206,382                   651,645
CDRH 1,560,700 1,299,624 1,935,744                   4,796,068
CVM 17,079 17,163 22,344                   56,586
OC 21,318 17,298 13,116                   51,732
CTP 531 801 1,047                   2,379
ACA 9 48 720                   777
GDUFA 45 33 144                   222
CFSAN 312 340 436                   1,088
HC 9,030 9,045 10,842                   28,917
ORA 0 2 4                   6
Totals 2,282,149 2,010,289 2,676,322                   6,968,760

FDA ESG 2021 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 182,833 185,634 198,270 183,702 200,409 184,877 219,943 193,590 191,144 169,348 175,952 201,728 2,287,430
CDER 19,068 20,894 24,711 23,577 23,440 24,812 23,754 23,795 24,783 25,164 24,230 24,907 283,135
CBER 18,930 26,675 31,183 46,014 46,600 56,094 71,441 137,355 75,191 66,984 65,970 74,088 716,525
CDRH 323,386 252,371 332,767 288,054 269,252 324,867 339,939 381,403 268,729 323,952 319,559 350,446 3,774,725
CVM 5,910 5,890 7,728 6,752 7,498 8,592 7,783 8,526 7,330 7,676 7,988 6,543 88,216
OC 5,649 4,004 5,004 4,988 3,856 4,794 4,389 3,802 3,529 5,792 5,870 7,166 58,843
CTP 420 498 523 334 375 691 484 432 644 252 246 197 5,096
ACA 6 23 158 19 5 1 1 7 1 2 5 5 233
GDUFA 19 21 25 32 263 92 33 23 18 25 25 263 839
CFSAN 175 190 211 248 196 254 213 215 191 247 231 169 2,540
HC 3,157 3,259 3,869 3,236 3,231 3,619 3,589 3,310 3,257 3,308 3,344 3,213 40,392
ORA       3 5 3 15 9 1 9 8 4 57
Totals 559,553 499,459 604,449 556,959 555,130 608,696 671,584 752,467 574,818 602,759 603,428 668,729 7,258,031
FDA ESG 2021 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 182,833 185,634 198,270 183,702 200,409 184,877 219,943 193,590 191,144 169,348 175,952 201,728 2,287,430
CDER 38,136 41,788 49,422 47,154 46,880 49,624 47,508 47,590 49,566 50,328 48,460 49,814 566,270
CBER 37,860 53,350 62,366 92,028 93,200 112,188 142,882 274,710 150,382 133,968 131,940 148,176 1,433,050
CDRH 970,158 757,113 998,301 864,162 807,756 974,601 1,019,817 1,144,209 806,187 971,856 958,677 1,051,338 11,324,175
CVM 11,820 11,780 15,456 13,504 14,996 17,184 15,566 17,052 14,660 15,352 15,976 13,086 176,432
OC 11,298 8,008 10,008 9,976 7,712 9,588 8,778 7,604 7,058 11,584 11,740 14,332 117,686
CTP 840 996 1,046 668 750 1,382 968 864 1,288 504 492 394 10,192
ACA 12 46 316 38 10 2 2 14 2 4 10 10 466
GDUFA 38 42 50 64 526 184 66 46 36 50 50 526 1,678
CFSAN 175 190 211 248 196 254 213 215 191 247 231 169 2,540
HC 6,314 6,518 7,738 6,472 6,462 7,238 7,178 6,620 382 494 462 338 56,216
ORA       3 5 3 15 9 1 9 8 4 57
Totals 1,259,484 1,065,465 1,339,526 1,218,019 1,178,902 1,357,125 1,462,936 1,692,523 1,220,897 1,353,744 1,343,998 1,479,915 15,972,534
FDA ESG 2021 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 365,666 371,268 396,540 367,404 400,818 369,754 439,886 387,180 382,288 338,696 351,904 403,456 4,574,860
CDER 57,204 62,682 74,133 70,731 70,320 74,436 71,262 71,385 74,349 75,492 72,690 74,721 849,405
CBER 56,790 80,025 93,549 138,042 139,800 168,282 214,323 412,065 225,573 200,952 197,910 222,264 2,149,575
CDRH 1,293,544 1,009,484 1,331,068 1,152,216 1,077,008 1,299,468 1,359,756 1,525,612 1,074,916 1,295,808 1,278,236 1,401,784 15,098,900
CVM 17,730 17,670 23,184 20,256 22,494 25,776 23,349 25,578 21,990 23,028 23,964 19,629 264,648
OC 16,947 12,012 15,012 14,964 11,568 14,382 13,167 11,406 10,587 17,376 17,610 21,498 176,529
CTP 1,260 1,494 1,569 1,002 1,125 2,073 1,452 1,296 1,932 756 738 591 15,288
ACA 18 69 474 57 15 3 3 21 3 6 15 15 699
GDUFA 57 63 75 96 789 276 99 69 54 75 75 789 2,517
CFSAN 350 380 422 496 392 508 426 430 382 494 462 338 5,080
HC 9,471 9,777 11,607 9,708 9,693 10,857 10,767 9,930 573 741 693 507 84,324
ORA       6 10 6 30 18 2 18 16 8 114
Totals 1,819,037 1,564,924 1,943,975 1,774,978 1,734,032 1,965,821 2,134,520 2,444,990 1,792,649 1,953,442 1,944,313 2,145,600 23,218,281
 

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