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Submission Statistics

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FDA ESG 2009-2019 Total Submission Statistics
  2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Totals
AERS 300,672 472,142 557,917 717,345 876,475 1,026,314 1,321,114 1,533,378 1,698,094 2,118,827 1,304,627 11,926,905
CDER 45,510 69,739 93,503 107,681 124,232 139,322 159,515 165,932 189,141 221,471 136,147 1,452,193
CBER 4,483 5,588 6,397 6,927 8,412 9,506 11,294 20,278 52,197 56,044 39,588 220,714
CDRH 21,296 119,087 280,312 462,316 666,927 812,443 1,478,524 2,032,767 1,921,871 2,247,286 1,470,396 11,513,225
CVM 859 2,083 20,462 37,928 40,978 44,607 52,601 64,197 70,436 70,682 42,802 447,635
OC 16,275 48,232 55,676 64,285 65,430 68,171 60,943 56,517 71,545 77,353 34,009 618,436
CTP 5 223 348 642 1,237 324 734 612 23,984 19,142 2,035 49,286
ACA       62 207 195 212 228 218 236 264 1,622
GDUFA       2,771 2,926 3,547 2,906 1,644 1,600 1,455 1,113 17,962
CFSAN       458 4,220 2,756 3,761 3,619 2,661 2,421 1,430 21,326
HC         324 5,835 9,366 16,497 23,595 26,927 16,289 98,833
Totals 389,100 717,094 1,014,615 1,400,415 1,791,368 2,113,020 3,100,970 3,895,669 4,055,342 4,841,844 3,048,700 26,368,137
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           1,304,627
CDER 19,240 18,243 17,909 20,252 21,024 19,132 20,347           136,147
CBER 5,820 5,041 5,526 5,189 6,015 5,215 6,782           39,588
CDRH 236,293 198,378 227,468 210,646 196,542 191,825 209,244           1,470,396
CVM 5,704 5,305 5,436 5,833 6,662 6,511 7,351           42,802
OC 6,283 4,987 6,038 4,442 4,305 4,226 3,728           34,009
CTP 235 182 230 317 312 483 276           2,035
ACA 8 21 184 34 7 4 6           264
GDUFA 23 19 49 23 855 109 35           1,113
CFSAN 204 200 201 171 262 191 201           1,430
HC 2,376 2,059 2,252 2,256 2,352 2,273 2,721           16,289
Totals 457,267 418,657 439,174 434,097 418,617 403,098 477,790 0 0 0 0 0 3,048,700
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           1,304,627
CDER 38,480 36,486 35,818 40,504 42,048 38,264 40,694           272,294
CBER 11,640 10,082 11,052 10,378 12,030 10,430 13,564           79,176
CDRH 708,879 595,134 682,404 631,938 589,626 575,475 627,732           4,411,188
CVM 11,408 10,610 10,872 11,666 13,324 13,022 14,702           85,604
OC 6,283 9,974 12,076 8,884 8,610 8,452 7,456           68,018
CTP 470 364 460 634 624 966 552           4,070
ACA 16 42 368 68 14 8 12           528
GDUFA 46 38 98 46 1,710 218 70           2,226
CFSAN 204 200 201 171 262 191 201           1,430
HC 4,752 4,118 4,504 4,512 4,704 4,546 5,442           32,578
Totals 969,542 851,270 931,734 893,735 853,233 824,701 937,524 0 0 0 0 0 6,261,739
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           2,609,254
CDER 57,720 54,729 53,727 60,756 63,072 57,396 61,041           408,441
CBER 17,460 15,123 16,578 15,567 18,045 15,645 20,346           118,764
CDRH 945,172 793,512 909,872 842,584 786,168 767,300 836,976           5,881,584
CVM 17,112 15,915 16,308 17,499 19,986 19,533 22,053           128,406
OC 18,849 14,961 18,114 13,326 12,915 12,678 11,184           102,027
CTP 705 546 690 951 936 1,449 828           6,105
ACA 24 63 552 102 21 12 18           792
GDUFA 69 57 147 69 2,565 327 105           3,339
CFSAN 408 400 402 342 524 382 402           2,860
HC 7,128 6,177 6,756 6,768 7,056 6,819 8,163           48,867
Totals 1,426,809 1,269,927 1,370,908 1,327,832 1,271,850 1,227,799 1,415,314 0 0 0 0 0 9,310,439

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FDA ESG 2018 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 193,303 155,234 168,917 189,439 187,585 182,567 199,129 170,493 160,190 178,549 173,019 160,402 2,118,827
CDER 17,149 20,811 18,210 17,312 18,739 19,156 17,931 19,766 17,354 18,564 18,364 18,115 221,471
CBER 3,227 3,535 3,479 3,348 3,503 4,706 6,022 5,582 4,799 6,661 5,562 5,620 56,044
CDRH 159,841 150,260 167,525 163,605 162,229 215,421 162,003 244,031 240,069 216,559 193,536 18,115 2,247,286
CVM 4,881 5,155 5,753 5,488 7,035 6,436 7,040 6,174 5,324 6,649 5,520 5,227 70,682
OC 7,137 4,729 4,744 4,824 5,262 4,802 4,174 4,795 4,123 7,721 9,607 15,435 77,353
CTP 123 274 139 972 2,015 215 106 269 437 7,293 6,946 353 19,142
MWP 0 0 0 0 0 0 0 0 0 0 0 0 0
ACA 0 9 170 34 3 3 2 7 3 2 1 2 236
GDUFA 44 11 20 19 945 161 75 35 28 36 44 37 1,455
CFSAN 261 184 221 208 212 199 248 193 132 164 207 192 2,421
HC 1,895 2,088 2,227 2,274 2,450 2,452 2,414 2,492 1,955 2,240 2,374 2,066 26,927
Totals 387,861 342,290 371,405 387,523 389,978 436,118 399,144 453,837 434,414 444,478 415,180 379,616 4,841,844
FDA ESG 2018 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 193,303 155,234 168,917 189,439 187,585 182,567 199,129 170,493 160,190 178,549 173,019 160,402 2,118,827
CDER 34,298 41,622 36,420 34,624 37,478 38,312 35,862 39,532 34,708 37,128 36,728 36,230 442,942
CBER 3,227 3,535 3,479 3,348 3,503 4,706 6,022 5,582 4,799 13,322 11,124 11,240 73,887
CDRH 479,523 450,780 502,575 490,815 486,687 646,263 486,009 732,093 720,207 649,797 580,608 516,501 6,741,858
CVM 9,762 10,310 11,506 10,976 14,070 12,872 14,080 12,348 10,648 13,298 11,040 10,454 141,364
OC 14,274 9,458 9,488 9,648 10,524 9,604 8,348 9,590 8,246 15,442 19,214 15,435 139,271
CTP 246 548 278 1,944 4,030 430 212 538 874 14,586 13,892 706 38,284
MWP 0 0 0 0 0 0 0 0 0 0 0 0 0
ACA 0 9 170 34 3 3 2 7 3 2 1 4 238
GDUFA 44 11 20 19 945 161 75 35 28 36 44 74 1,492
CFSAN 261 184 221 208 212 199 248 193 132 164 207 192 2,421
HC 3,790 4,176 4,454 4,548 4,900 4,904 4,828 4,984 3,910 4,480 4,748 4,132 53,854
Totals 738,728 675,867 737,528 745,603 749,937 900,021 754,815 975,395  943,745 926,804 850,625 755,370 9,754,438
FDA ESG 2018 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 386,606 310,468 337,834 378,878 375,170 365,134 398,258 340,986 320,380 357,098 346,038 320,804 4,237,654
CDER 51,447 62,433 54,630 51,936 56,217 57,468 53,793 59,298 52,062 55,692 55,092 54,345 664,413
CBER 6,454 7,070 6,958 6,696 7,006 9,412 12,044 11,164 9,598 19,983 16,686 16,860 129,931
CDRH 639,364 601,040 670,100 654,420 648,916 861,684 648,012 976,124 960,276 866,396 774,144 688,668 8,989,144
CVM 14,643 15,465 17,259 16,464 21,105 19,308 21,120 18,522 15,972 19,947 16,560 15,681 212,046
OC 21,411 14,187 14,232 14,472 15,786 14,406 12,522 14,385 12,369 23,163 28,821 30,870 216,624
CTP 369 822 417 2,916 6,045 645 318 807 1,311 21,879 20,838 1,059 57,426
MWP 0 0 0 0 0 0 0 0 0 0 0 0 0
ACA 0 18 340 68 6 6 4 14 6 4 2 6 474
GDUFA 88 22 40 38 1,890 322 150 70 56 72 88 111 2,947
CFSAN 522 368 442 416 424 398 496 386 264 328 414 384 4,842
5,865 5,685 6,264 6,681 6,822 7,350 7,356 7,242 7,476 5,865 6,720 7,122 6,198 80,781
Totals 1,126,589 1,018,157 1,108,933 1,133,126 1,139,915 1,336,139 1,153,959 1,429,232 1,378,159 1,371,282 1,265,805 1,134,986 14,596,282