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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 2,160,138 18,123,638
CDER 107,681 124,232 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 262,838 2,149,135
CBER 6,927 8,412 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 623,618 1,650,246
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 4,493,710 23,625,862
CVM 37,928 40,978 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 79,251 710,083
OC 64,285 65,430 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 52,592 725,597
CTP 642 1,237 324 734 612 23,984 19,142 3,698 10,563 5,096 4,416 70,448
ACA 62 207 195 212 228 218 236 271 288 233 294 2,444
GDUFA 2,771 2,926 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 938 21,180
CFSAN 458 4,220 2,756 3,761 3,619 2,661 2,421 2,261 2,160 2,540 2,053 28,910
HC   324 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 34,645 220,050
ORA                   57 49 106
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 7,714,542 47,327,699

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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   2,160,138
CDER 21,590 24,083 26,823 23,048 24,172 24,461 22,173 24,453 25,146 22,797 24,092   262,838
CBER 73,087 75,334 68,794 56,245 53,078 57,907 61,450 55,999 62,999 30,590 28,135   623,618
CDRH 390,175 324,906 483,936 455,025 605,425 545,287 381,067 354,037 315,585 305,232 333,035   4,493,710
CVM 5,693 5,721 7,448 6,824 7,829 7,676 7,186 9,273 7,128 7,100 7,373   79,251
OC 7,106 5,766 4,372 4,780 3,889 3,867 3,070 3,406 3,486 5,655 7,195   52,592
CTP 177 267 349 207 1,615 273 376 279 312 209 352   4,416
ACA 3 16 240 20 8 0 2 0 2 2 1   294
GDUFA 15 11 48 22 669 71 17 18 24 24 19   938
CFSAN 156 170 218 167 246 195 204 237 152 178 130   2,053
HC 3,010 3,015 3,614 3,052 3,123 3,312 3,171 3,138 3,040 2,909 3,261   34,645
ORA 0 1 2 2 2 2 0 22 0 8 10   49
Totals 695,559 623,132 798,381 726,603 889,014 849,554 672,423 648,041 618,811 581,614 611,410   7,714,542
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   2,160,138
CDER 43,180 48,166 53,646 46,096 48,344 48,922 44,346 48,906 50,292 45,594 48,184   525,676
CBER 146,174 150,668 137,588 112,490 106,156  115,814 122,900 111,998 125,998 61,180 56,270   1,247,236
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   13,481,130
CVM 11,386 11,442 14,896 13,648 15,658 15,352 14,372 18,546 14,256 14,200 14,746   158,502
OC 14,212 11,532 8,744 9,560 7,778 7,734 6,140 6,812 6,972 11,310 14,390   105,184
CTP 354 534 698 414 3,230 546 752 558 624 418 704   8,832
ACA 6 32 480 40 16 0 4 0 4 4 2   588
GDUFA 30 22 96 44 1,338 142 34 36 48 48 38   1,876
CFSAN 156 170 218 167 246 195 204 237 152 178 130   2,053
HC 6,020 6,030 7,228 6,104 6,246 6,624 6,342 6,276 6,080 5,818 6,522   69,290
ORA 0 1 2 2 2 2 0 22 0 8 10   49
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   17,760,554

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   4,320,276
CDER 64,770 72,249 80,469 69,144 72,516 73,383 66,519 73,359 75,438 68,391 72,276   788,514
CBER 219,261 226,002 206,382 168,735 159,234 173,721 184,350 167,997 188,997 91,770 84,405   1,870,854
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   17,974,840
CVM 17,079 17,163 22,344 20,472 23,487 23,028 21,558 27,819 21,384 21,300 22,119   237,753
OC 21,318 17,298 13,116 14,340 11,667 11,601 9,210 10,218 10,458 16,965 21,585   157,776
CTP 531 801 1,047 621 4,845 819 1,128 837 936 627 1,056   13,248
ACA 9 48 720 60 24 0 6 0 6 6 3   882
GDUFA 45 33 144 66 2,007 213 51 54 72 72 57   2,814
CFSAN 312 340 436 334 492 390 408 474 304 356 260   4,106
HC 9,030 9,045 10,842 9,156 9,369 9,936 9,513 9,414 9,120 8,727 9,783   103,935
ORA 0 2 4 4 4 4 0 44 0 16 20   98
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   25,475,096

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 6,514 6,616 6,688 6,426 80,784
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 1,227,029 1,359,866 1,350,224 1,486,003 16,000,760
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 9,771 9,924 10,032 9,639 121,176
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 1,801,847 1,962,625 1,953,652 2,154,732 23,258,791
 

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