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Submission Statistics

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FDA ESG 2008-2018 Total Submission Statistics
  2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Totals
AERS 252,614 300,672 472,142 557,917 717,345 876,475 1,026,314 1,321,114 1,533,378 1,698,094 1,077,045 10,047,828
CDER 24,797 45,510 69,739 93,503 107,681 124,232 139,322 159,515 165,932 189,141 111,377 1,243,563
CBER 2,557 4,483 5,588 6,397 6,927 8,412 9,506 11,294 20,278 52,197 21,798 151,235
CDRH 4,619 21,296 119,087 280,312 462,316 666,927 812,443 1,478,524 2,032,767 1,921,871 1,018,881 8,822,145
CVM 843 859 945 17,932 35,429 40,241 43,776 50,738 63,404 70,436 34,748 359,639
OC 188 16,275 48,232 55,676 64,285 65,430 68,171 60,943 56,517 71,545 31,498 538,760
CTP   5 223 348 642 1,237 324 734 612 23,984 3,738 31,847
MWP     1,138 2,530 2,499 737 831 1,863 793 0 0 10,391
ACA         62 207 195 212 228 218 219 1,341
GDUFA         2,771 2,926 3,547 2,906 1,644 1,600 1,200 16,594
CFSAN         458 4,220 2,756 3,761 3,619 2,661 1,285 18,760
HC           324 5,835 9,366 16,497 23,595 13,386 69,003
Totals 285,618 389,100 717,094 1,014,615 1,400,415 1,791,368 2,113,020 3,100,970 3,895,669 4,055,342 2,315,175 21,311,106
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             1,077,045
CDER 17,149 20,811 18,210 17,312 18,739 19,156             111,377
CBER 3,227 3,535 3,479 3,348 3,503 4,706             21,798
CDRH 159,841 150,260 167,525 163,605 162,229 215,421             1,018,881
CVM 4,881 5,155 5,753 5,488 7,035 6,436             34,748
OC 7,137 4,729 4,744 4,824 5,262 4,802             31,498
CTP 123 274 139 972 2,015 215             3,738
MWP 0 0 0 0 0 0             0
ACA 0 9 170 34 3 3             219
GDUFA 44 11 20 19 945 161             1,200
CFSAN 261 184 221 208 212 199             1,285
HC 1,895 2,088 2,227 2,274 2,450 2,452             13,386
Totals 387,861 342,290 371,405 387,523 389,978 436,118             2,315,175
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             1,077,045
CDER 34,298 41,622 36,420 34,624 37,478 38,312             222,754
CBER 3,227 3,535 3,479 3,348 3,503 4,706             21,798
CDRH 479,523 450,780 502,575 490,815 486,687 646,263             3,056,643
CVM 9,762 10,310 11,506 10,976 14,070 12,872             69,496
OC 14,274 9,458 9,488 9,648 10,524 9,604             62,996
CTP 246 548 278 1,944 4,030 430             7,476
MWP 0 0 0 0 0 0             0
ACA 0 9 170 34 3 3             219
GDUFA 44 11 20 19 945 161             1,200
CFSAN 261 184 221 208 212 199             1,285
HC 3,790 4,176 4,454 4,548 4,900 4,904             26,772
Totals 738,728 675,867 737,528 745,603 749,937 900,021             4,547,684
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             2,154,090
CDER 51,447 62,433 54,630 51,936 56,217 57,468             334,131
CBER 6,454 7,070 6,958 6,696 7,006 9,412             43,596
CDRH 639,364 601,040 670,100 654,420 648,916 861,684             4,075,524
CVM 14,643 15,465 17,259 16,464 21,105 19,308             104,244
OC 21,411 14,187 14,232 14,472 15,786 14,406             94,494
CTP 369 822 417 2,916 6,045 645             11,214
MWP 0 0 0 0 0 0             0
ACA 0 18 340 68 6 6             438
GDUFA 88 22 40 38 1,890 322             2,400
CFSAN 522 368 442 416 424 398             2,570
HC 5,685 6,264 6,681 6,822 7,350 7,356             40,158
Totals 1,126,589 1,018,157 1,108,933 1,133,126 1,139,915 1,336,139             6,862,859
FDA ESG 2017 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 132,260 139,651 148,193 133,979 140,483 143,564 145,394 147,858 134,031 161,900 126,763 144,018 1,698,094
CDER 13,896 14,315 16,690 14,392 16,468 17,334 14,563 16,978 16,238 16,026 16,198 16,043 189,141
CBER 3,907 4,251 4,476 4,381 6,095 4,265 4,186 5,086 4,625 4,490 3,507 2,928 52,197
CDRH 134,720 135,026 147,500 132,215 137,605 160,925 142,492 147,453 292,757 185,161 156,804 149,213 1,921,871
CVM 4,883 4,254 5,786 7,000 6,716 6,734 6,360 6,793 5,479 6,225 5,583 4,623 70,436
OC 4,815 4,578 4,323 4,052 4,709 4,885 4,064 4,316 3,704 6,758 9,434 15,907 71,545
CTP 155 1,179 16,537 165 233 420 386 407 306 1,505 2,488 203 23,984
MWP 0 0 0 0 0 0 0 0 0 0 0 0 0
ACA 7 10 149 31 7 2 3 1 3 1 1 3 218
GDUFA 37 11 22 25 1,118 127 53 23 33 50 49 52 1,600
CFSAN 197 211 231 201 302 344 205 196 150 261 190 173 2,661
HC 1,579 1,729 2,145 1,878 2,076 2,050 2,110 2,041 1,879 2,062 2,108 1,938 23,595
Totals 296,456 305,215 346,052 298,319 315,812 340,650 319,816 331,152 459,205 384,439 323,125 335,101 4,055,342
FDA ESG 2017 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 132,260 139,651 148,193 133,979 140,483 143,564 145,394 147,858 134,031 161,900 126,763 144,018 1,698,094
CDER 27,792 28,630 33,380 28,784 32,936 34,668 29,126 33,956 32,476 32,052 32,396 32,086 378,282
CBER 3,907 4,251 4,476 4,381 6,095 4,265 4,186 5,086 4,625 4,490 3,507 2,928 52,197
CDRH 404,160 405,078 442,500 396,645 412,815 482,775 427,476 442,359 878,271 555,483 470,412 447,639 5,765,613
CVM 9,766 8,508 11,572 14,000 13,432 13,468 12,720 13,586 10,958 12,450 11,166 9,246 140,872
OC 9,630 9,156 8,646 8,104 9,418 9,770 8,128 8,632 7,408 13,516 18,868 31,814 143,090
CTP 310 2,358 33,074 330 466 840 772 814 612 3,010 4,976 406 47,968
MWP 0 0 0 0 0 0 0 0 0 0 0 0 0
ACA 7 10 149 31 7 2 3 1 3 1 1 3 218
GDUFA 37 11 22 25 1,118 127 53 23 33 50 49 52 1,600
CFSAN 197 211 231 201 302 344 205 196 150 261 190 173 2,661
HC 3,158 3,458 4,290 3,756 4,152 4,100 4,220 4,082 3,758 4,124 4,216 3,876 47,190
Totals 591,224 601,322 686,533 590,236 621,224 693,923 632,283 656,593 1,072,325 787,337 672,544 672,241 8,277,785
FDA ESG 2017 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 264,520 279,302 296,386 267,958 280,966 287,128 290,788 295,716 268,062 323,800 253,526 288,036 3,396,188
CDER 41,688 42,945 50,070 43,176 49,404 52,002 43,689 50,934 48,714 48,078 48,594 48,129 567,423
CBER 7,814 8,502 8,952 8,762 12,190 8,530 8,372 10,172 9,250 8,980 7,014 5,856 104,394
CDRH 538,880 540,104 590,000 528,860 550,420 643,700 569,968 589,812 1,171,028 740,644 627,216 596,852 7,687,484
CVM 14,649 12,762 17,358 21,000 20,148 20,202 19,080 20,379 16,437 18,675 16,749 13,869 211,308
OC 14,445 13,734 12,969 12,156 14,127 14,655 12,192 12,948 11,112 20,274 28,302 47,721 214,635
CTP 465 3,537 49,611 495 699 1,260 1,158 1,221 918 4,515 7,464 609 71,952
MWP 0 0 0 0 0 0 0 0 0 0 0 0 0
ACA 14 20 298 62 14 4 6 2 6 2 2 6 436
GDUFA 74 22 44 50 2,236 254 106 46 66 100 98 104 3,200
CFSAN 394 422 462 402 604 688 410 392 300 522 380 346 5,322
HC 4,737 5,187 6,435 5,634 6,228 6,150 6,330 6,123 5,637 6,186 6,324 5,814 70,785
Totals 887,680 906,537 1,032,585 888,555 937,036 1,034,573 952,099 987,745 1,531,530 1,171,776 995,669 1,007,342 12,333,127

 

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