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Submission Statistics

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FDA ESG 2011-2021 Total Submission Statistics
  2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Totals
AERS 557,917 717,345 876,475 1,026,314 1,321,114 1,533,378 1,698,094 2,118,827 2,160,020 2,224,503 2,287,430 16,521,417
CDER 93,503 107,681 124,232 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 1,979,800
CBER 6397 6,927 8,412 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 1,033,025
CDRH 280,312 462,316 666,927 812,443 1,478,524 2,032,767 1,921,871 2,247,286 2,774,852 2,960,441 3,774,725 19,412,464
CVM 20,462 37,928 40,978 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 651,294
OC 55,676 64,285 65,430 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 728,681
CTP 348 642 1,237 324 734 612 23,984 19,142 3,698 10,563 5,096 66,380
ACA   62 207 195 212 228 218 236 271 288 233 2,150
GDUFA   2,771 2,926 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 20,242
CFSAN   458 4,220 2,756 3,761 3,619 2,661 2,421 2,261 2,160 2,540 26,857
HC     324 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 185,405
ORA                     57 57
Totals 1,014,615 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 40,627,772
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

FDA ESG 2020 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 204,918 180,498 186,259 184,920 173,310 182,363 194,758 172,313 182,097 185,758 180,080 197,229 2,224,503
CDER 19,770 19,397 21,774 22,023 20,616 22,158 22,676 20,603 22,397 23,368 21,141 23,361 259,284
CBER 6,325 5,477 6,888 6,422 4,985 5,001 6,066 5,486 5,720 6,506 6,590 9,079 74,545
CDRH 261,384 233,864 250,764 225,618 192,993 236,836 250,483 216,666 253,108 265,993 279,854 292,878 2,960,441
CVM 6,447 6,087 7,019 6,032 6,725 8,817 8,529 7,235 7,971 7,768 6,772 7,035 86,437
OC 8,511 4,687 5,083 5,860 6,298 5,460 5,001 4,536 4,313 7,658 6,441 9,521 73,369
CTP 268 466 428 873 462 469 690 1,223 4,387 677 314 306 10,563
ACA 2 17 201 39 3 2 1 6 3 12 0 2 288
GDUFA 24 14 10 24 924 103 40 19 8 13 34 36 1,249
CFSAN 148 174 144 116 183 176 231 276 170 181 182 179 2,160
HC 2,238 2,424 2,817 2,553 2,655 2,964 3,130 2,744 3,105 3,384 3,473 3,680 35,167
Totals 510,035 453,105 481,387 454,480 409,154 464,349 491,605 431,107 483,279 501,318 504,881 543,306 5,728,006
FDA ESG 2020 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 204,918 180,498 186,259 184,920 173,310 182,363 194,758 172,313 182,097 185,758 180,080 197,229 2,224,503
CDER 39,540 38,794 43,548 44,046 41,232 44,316 45,352 41,206 44,794 46,736 42,282 46,722 518,568
CBER 12,650 10,954 13,776 12,844 9,970 10,002 12,132 10,972 11,440 13,012 13,180 18,158 149,090
CDRH 784,152 701,592 752,292 676,854 578,979 710,508 751,449 649,998 759,324 797,979 839,562 878,634 8,881,323
CVM 12,894 12,174 14,038 12,064 13,450 17,634 17,058 14,470 15,942 15,536 13,544 14,070 172,874
OC 17,022 9,374 10,166 11,720 12,596 10,920 10,002 9,072 8,626 15,316 12,882 19,042 146,738
CTP 536 932 856 1,746 924 938 1,380 2,446 8,774 1,354 628 612 21,126
ACA 4 34 402 78 6 4 2 12 6 24 0 4 576
GDUFA 48 28 20 48 1,848 206 80 38 16 26 68 72 2,498
CFSAN 148 174 144 116 183 176 231 276 170 181 182 179 2,160
HC 4,476 4,848 5,634 5,106 5,310 5,928 6,260 5,488 6,210 6,768 6,946 7,360 70,334
Totals 1,076,388 959,402 1,027,135 949,542 837,808 982,995 1,038,704 906,291 1,037,399 1,082,690 1,109,354 1,182,082 12,189,790
FDA ESG 2020 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 409,836 360,996 372,518 369,840 346,620 364,726 389,516 344,626 364,194 371,516 360,160 394,458 4,449,006
CDER 59,310 58,191 65,322 66,069 61,848 66,474 68,028 61,809 67,191 70,104 63,423 70,083 777,852
CBER 18,975 16,431 20,664 19,266 14,955 15,003 18,198 16,458 17,160 19,518 19,770 27,237 223,635
CDRH 1,045,536 935,456 1,003,056 902,472 771,972 947,344 1,001,932 866,664 1,012,432 1,063,972 1,119,416 1,171,512 11,841,764
CVM 19,341 18,261 21,057 18,096 20,175 26,451 25,587 21,705 23,913 23,304 20,316 21,105 259,311
OC 25,533 14,061 15,249 17,580 18,894 16,380 15,003 13,608 12,939 22,974 19,323 28,563 220,107
CTP 804 1,398 1,284 2,619 1,386 1,407 2,070 3,669 13,161 2,031 942 918 31,689
ACA 6 51 603 117 9 6 3 18 9 36 0 6 864
GDUFA 72 42 30 72 2,772 309 120 57 24 39 102 108 3,747
CFSAN 296 348 288 232 366 352 462 552 340 362 364 358 4,320
HC 6,714 7,272 8,451 7,659 7,965 8,892 9,390 8,232 9,315 10,152 10,419 11,040 105,501
Totals 1,586,423 1,412,507 1,508,522 1,404,022 1,246,962 1,447,344 1,530,309 1,337,398 1,520,678 1,584,008 1,614,235 1,725,388 17,917,796

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