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Submission Statistics

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FDA ESG 2010-2020 Total Submission Statistics
  2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Totals
AERS 472,142 557,917 717,345 876,475 1,026,314 1,321,114 1,533,378 1,698,094 2,118,827 2,160,020 1,661,436 14,143,062
CDER 69,739 93,503 107,681 124,232 139,322 159,515 165,932 189,141 221,471 236,584 191,414 1,698,534
CBER 5,588 6397 6,927 8,412 9,506 11,294 20,278 52,197 56,044 70,900 52,370 299,913
CDRH 119,087 280,312 462,316 666,927 812,443 1,478,524 2,032,767 1,921,871 2,247,286 2,774,852 2,121,716 14,918,101
CVM 2,083 20,462 37,928 40,978 44,607 52,601 64,197 70,436 70,682 74,750 64,862 543,586
OC 48,232 55,676 64,285 65,430 68,171 60,943 56,517 71,545 77,353 76,549 49,749 694,450
CTP 223 348 642 1,237 324 734 612 23,984 19,142 3,698 9,266 60,210
ACA     62 207 195 212 228 218 236 271 274 1,903
GDUFA     2,771 2,926 3,547 2,906 1,644 1,600 1,455 1,305 1,166 19,320
CFSAN     458 4,220 2,756 3,761 3,619 2,661 2,421 2,261 1,618 23,775
HC       324 5,835 9,366 16,497 23,595 26,927 27,302 24,630 134,476
Totals 717,094 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 4,178,501 32,537,330
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       1,661,436
CDER 19,770 19,397 21,774 22,023 20,616 22,158 22,676 20,603 22,397       191,414
CBER 6,325 5,477 6,888 6,422 4,985 5,001 6,066 5,486 5,720       52,370
CDRH 261,384 233,864 250,764 225,618 192,993 236,836 250,483 216,666 253,108       2,121,716
CVM 6,447 6,087 7,019 6,032 6,725 8,817 8,529 7,235 7,971       64,862
OC 8,511 4,687 5,083 5,860 6,298 5,460 5,001 4,536 4,313       49,749
CTP 268 466 428 873 462 469 690 1,223 4,387       9,266
ACA 2 17 201 39 3 2 1 6 3       274
GDUFA 24 14 10 24 924 103 40 19 8       1,166
CFSAN 148 174 144 116 183 176 231 276 170       1,618
HC 2,238 2,424 2,817 2,553 2,655 2,964 3,130 2,744 3,105       24,630
Totals 510,035 453,105 481,387 454,480 409,154 464,349 491,605 431,107 483,279       4,178,501
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       1,661,436
CDER 39,540 38,794 43,548 44,046 41,232 44,316 45,352 41,206 44,794       382,828
CBER 12,650 10,954 13,776 12,844 9,970 10,002 12,132 10,972 11,440       104,740
CDRH 784,152 701,592 752,292 676,854 578,979 710,508 751,449 649,998 759,324       6,365,148
CVM 12,894 12,174 14,038 12,064 13,450 17,634 17,058 14,470 15,942       129,724
OC 17,022 9,374 10,166 11,720 12,596 10,920 10,002 9,072 8,626       99,498
CTP 536 932 856 1,746 924 938 1,380 2,446 8,774       18,532
ACA 4 34 402 78 6 4 2 12 6       548
GDUFA 48 28 20 48 1,848 206 80 38 16       2,332
CFSAN 148 174 144 116 183 176 231 276 170       1,618
HC 4,476 4,848 5,634 5,106 5,310 5,928 6,260 5,488 6,210       49,260
Totals 1,076,388 959,402 1,027,135 949,542 837,808 982,995 1,038,704 906,291 1,037,399       8,815,664
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       3,322,872
CDER 59,310 58,191 65,322 66,069 61,848 66,474 68,028 61,809 67,191       574,242
CBER 18,975 16,431 20,664 19,266 14,955 15,003 18,198 16,458 17,160       157,110
CDRH 1,045,536 935,456 1,003,056 902,472 771,972 947,344 1,001,932 866,664 1,012,432       8,486,864
CVM 19,341 18,261 21,057 18,096 20,175 26,451 25,587 21,705 23,913       194,586
OC 25,533 14,061 15,249 17,580 18,894 16,380 15,003 13,608 12,939       149,247
CTP 804 1,398 1,284 2,619 1,386 1,407 2,070 3,669 13,161       27,798
ACA 6 51 603 117 9 6 3 18 9       822
GDUFA 72 42 30 72 2,772 309 120 57 24       3,498
CFSAN 296 348 288 232 366 352 462 552 340       3,236
HC 6,714 7,272 8,451 7,659 7,965 8,892 9,390 8,232 9,315       73,890
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       12,994,165

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FDA ESG 2019 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 181,081 184,222 173,881 184,934 180,281 173,129 227,099 175,299 170,006 166,754 160,326 183,008 2,160,020
CDER 19,240 18,243 17,909 20,252 21,024 19,132 20,347 20,369 19,500 21,441 19,031 20,096 236,584
CBER 5,820 5,041 5,526 5,189 6,015 5,215 6,782 6,500 5,548 5,979 6,514 6,771 70,900
CDRH 236,293 198,378 227,468 210,646 196,542 191,825 209,244 239,956 330,931 247,397 242,205  243,967 2,774,852
CVM 5,704 5,305 5,436 5,833 6,662 6,511 7,351 6,653 6,313 6,861 6,094 6,027 74,750
OC 6,283 4,987 6,038 4,442 4,305 4,226 3,728 4,318 5,805 9,168 10,013 13,236  76,549
CTP 235 182 230 317 312 483 276 396 430 284 202 351 3,698
ACA 8 21 184 34 7 4 6 2 2 1 1 1 271
GDUFA 23 19 49 23 855 109 35 19 45 30 49 49 1,305
CFSAN 204 200 201 171 262 191 201 138 140 166 213 174 2,261
HC 2,376 2,059 2,252 2,256 2,352 2,273 2,721 2,308 2,032 2,282 2,237 2,154 27,302
Totals 457,267 418,657 439,174 434,097 418,617 403,098 477,790 455,958 540,752 460,363 446,885 475,834 5,428,492
FDA ESG 2019 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 181,081 184,222 173,881 184,934 180,281 173,129 227,099 175,299 170,006 166,754 160,326 183,008 2,160,020
CDER 38,480 36,486 35,818 40,504 42,048 38,264 40,694 40,738 39,000 42,882 38,062 40,192 473,168
CBER 11,640 10,082 11,052 10,378 12,030 10,430 13,564 13,000 11,096 11,958 13,028 13,542 141,800
CDRH 708,879 595,134 682,404 631,938 589,626 575,475 627,732 719,868 992,793 742,191 726,615 731,901 8,324,556
CVM 11,408 10,610 10,872 11,666 13,324 13,022 14,702 13,306 12,626 13,722 12,188 12,054 149,500
OC 6,283 9,974 12,076 8,884 8,610 8,452 7,456 8,636 11,610 18,336 20,026 26,472 153,098
CTP 470 364 460 634 624 966 552 792 860 568 404 702 7,396
ACA 16 42 368 68 14 8 12 4 4 2 2 2 542
GDUFA 46 38 98 46 1,710 218 70 38 90 60 98 98 2,610
CFSAN 204 200 201 171 262 191 201 138 140 166 213 174 2,261
HC 4,752 4,118 4,504 4,512 4,704 4,546 5,442 4,616 4,064 4,564 4,474 4,308 54,604
Totals 969,542 851,270 931,734 893,735 853,233 824,701 937,524 976,435 1,242,289 1,001,203 975,436 1,012,453 11,469,555
FDA ESG 2019 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 362,162 368,444 347,762 369,868 360,562 346,258 454,198 350,598 340,012 333,508 320,652 366,016 4,320,040
CDER 57,720 54,729 53,727 60,756 63,072 57,396 61,041 61,107 58,500 64,323 57,093 60,288 709,752
CBER 17,460 15,123 16,578 15,567 18,045 15,645 20,346 19,500 16,644 17,937 19,542 20,313 212,700
CDRH 945,172 793,512 909,872 842,584 786,168 767,300 836,976 959,824 1,323,724 989,588 968,820 975,868 11,099,408
CVM 17,112 15,915 16,308 17,499 19,986 19,533 22,053 19,959 18,939 20,583 18,282 18,081 224,250
OC 18,849 14,961 18,114 13,326 12,915 12,678 11,184 12,954 17,415 27,504 30,039 39,708 229,647
CTP 705 546 690 951 936 1,449 828 1,188 1,290 852 606 1,053 11,094
ACA 24 63 552 102 21 12 18 6 6 3 3 3 813
GDUFA 69 57 147 69 2,565 327 105 57 135 90 147 147 3,915
CFSAN 408 400 402 342 524 382 402 276 280 332 426 348 4,522
HC 7,128 6,177 6,756 6,768 7,056 6,819 8,163 6,924 6,096 6,846 6,711 6,462 81,906
Totals 1,426,809 1,269,927 1,370,908 1,327,832 1,271,850 1,227,799 1,415,314 1,432,393 1,783,041 1,461,566 1,422,321 1,488,287 16,898,047

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