For Industry

Submission Statistics

FDA ESG 2006-2015 Total Submission Statistics
  2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Totals
AERS 55,156 159,562 252,614 300,672 472,142 557,917 717,345 876,475 1,026,314 735,638 5,153,835
CDER 1,639 11,175 24,797 45,510 69,739 93,503 107,681 124,232 139,322 91,378 708,976
CBER 294 1,504 2,557 4,483 5,588 6,397 6,927 8,412 9,506 6,099 51,767
CDRH 1,575 1,527 4,619 21,296 119,087 280,312 462,316 666,927 812,443 617,077 2,987,179
CVM   288 843 859 945 17,932 35,429 40,241 43,776 28,390 168,703
OC     188 16,275 48,232 55,676 64,285 65,430 68,171 34,230 352,487
CTP       5 223 348 642 1,237 324 394 3,173
MWP         1,138 2,530 2,499 737 831 817 8,552
ACA             62 207 195 209 673
GDUFA             2,771 2,926 3,547 2,719 11,963
CFSAN             458 4,220 2,756 2,086 9,520
HC               324 5,835 5,297 11,456
Totals 58,664 174,056 285,618 389,100 717,094 1,014,615 1,400,415 1,791,368 2,113,020 1,524,334 9,468,284
FDA ESG 2015 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 82,921 160,008 110,499 93,229 84,451 96,088 108,442           735,638
CDER 11,232 12,242 13,696 13,586 12,938 13,513 14,171           91,378
CBER 819 753 858 865 807 925 1,072           6,099
CDRH 70,910 71,885 76,185 85,866 72,520 107,745 131,966           617,077
CVM 3,129 3,286 3,554 4,308 4,435 4,758 4,920           28,390
OC 5,380 4,650 4,706 5,194 4,625 5,307 4,368           34,230
CTP 20 71 17 81 141 32 32           394
MWP 92 83 101 133 181 132 95           817
ACA 4 18 118 54 12 1 2           209
GDUFA 89 79 97 78 2,127 182 67           2,719
CFSAN 462 418 435 342 253 88 88           2,086
HC 724 630 753 651 706 708 1,125           5,297
Totals 175,782 254,123 211,019 204,387 183,196 229,479 266,348 0 0 0 0 0 1,524,334
FDA ESG 2015 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 82,921 160,008 110,499 93,229 84,451 96,088 108,442           735,638
CDER 11,232 12,242 13,696 13,586 12,938 13,513 14,171           91,378
CBER 819 753 858 865 807 925 1,072           6,099
CDRH 212,730 215,655 228,555 257,598 217,560 323,235 395,898           1,851,231
CVM 6,258 6,572 7,108 8,616 8,870 9,516 9,840           56,780
OC 5,380 4,650 4,706 5,194 4,625 5,307 4,368           34,230
CTP 40 142 34 162 282 64 64           788
MWP 92 83 101 133 181 132 95           817
ACA 4 18 118 54 12 1 2           209
GDUFA 89 79 97 78 2,127 182 67           2,719
CFSAN 462 418 435 342 253 88 88           2,086
HC 724 630 753 651 706 708 1,125           5,297
Totals 320,751 401,250 366,960 380,508 332,812 449,759 535,232 0 0 0 0 0 2,787,272
FDA ESG 2015 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 165,842 320,016 220,998 186,458 168,902 192,176 216,884           1,471,276
CDER 22,464 24,484 27,392 27,172 25,876 27,026 28,342           182,756
CBER 1,638 1,506 1,716 1,730 1,614 1,850 2,144           12,198
CDRH 283,640 287,540 304,740 343,464 290,080 430,980 527,864           2,468,308
CVM 9,387 9,858 10,662 12,924 13,305 14,274 14,760           85,170
OC 10,760 9,300 9,412 10,388 9,250 10,614 8,736           68,460
CTP 60 213 51 243 423 96 96           1,182
MWP 184 166 202 266 362 264 190           1,634
ACA 8 36 236 108 24 2 4           418
GDUFA 178 158 194 156 4,254 364 134           5,438
CFSAN 924 836 870 684 506 176 176           4,172
HC 1,448 1,260 1,506 1,302 1,412 1,416 2,250           10,594
Totals 496,533 655,373 577,979 584,895 516,008 679,238 801,580 0 0 0 0 0 4,311,606
FDA ESG 2014 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 77,484 88,356 118,217 104,996 70,062 73,729 103,209 73,588 77,413 87,268 69,347 82,645 1,026,314
CDER 10,242 10,760 11,293 11,293 11,495 12,270 12,388 11,840 11,741 12,295 11,036 12,669 139,322
CBER 630 750 762 845 792 795 857 783 830 929 718 815 9,506
CDRH 60,364 69,384 65,000 68,372 54,327 60,037 64,162 67,556 85,670 79,260 62,015 76,296 812,443
CVM 2,484 2,439 2,772 3,383 3,533 3,758 4,454 4,279 4,230 4,813 3,539 4,092 43,776
OC 6,049 4,751 5,137 5,998 5,515 5,280 5,146 4,818 4,773 8,202 5,445 7,057 68,171
CTP 30 37 28 38 24 18 27 31 21 23 26 21 324
MWP 45 57 57 78 63 77 93 77 74 76 72 26 831
ACA 7 11 96 45 10 13 6 4 0 1 1 1 195
GDUFA 113 96 46 177 2,276 260 108 135 104 90 62 80 3,547
CFSAN 182 147 253 220 337 239 226 199 240 181 239 293 2,756
HC 195 310 364 399 445 477 781 643 518 569 570 564 5,835
Totals 157,825 177,098 204,025 195,844 148,879 156,953 191,457 163,953 185,614 193,707 153,070 184,595 2,113,020
FDA ESG 2014 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 77,484 88,356 118,217 104,996 70,062 73,729 103,209 73,588 77,413 87,268 69,347 82,645 1,026,314
CDER 10,242 10,760 11,293 11,293 11,495 12,270 12,388 11,840 11,741 12,295 11,036 12,669 139,322
CBER 630 750 762 845 792 795 857 783 830 929 718 815 9,506
CDRH 181,092 208,152 195,000 205,116 162,981 180,111 192,486 202,668 257,010 237,780 186,045 228,888 2,437,329
CVM 4,968 4,878 5,544 6,766 7,066 7,516 8,908 8,558 8,460 9,626 7,078 8,184 87,552
OC 6,049 4,751 5,137 5,998 5,515 5,280 5,146 4,818 4,773 8,202 5,445 7,057 68,171
CTP 60 74 56 76 48 36 54 62 42 46 52 42 648
MWP 45 57 57 78 63 77 93 77 74 76 72 62 831
ACA 7 11 96 45 10 13 6 4 0 1 1 1 195
GDUFA 113 96 46 177 2,276 260 108 135 104 90 62 80 3,547
CFSAN 182 147 253 220 337 239 226 198 240 182 239 293 2,756
HC 195 310 364 399 445 477 781 643 518 569 570 564 5,835
Totals 280,885 318,342 336,825 336,009 261,090 280,803 324,262 303,374 361,205 357,064 280,665 341,300 3,782,006
FDA ESG 2014 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 154,968 176,712 236,434 209,992 140,124 147,458 206,418 147,176 154,826 174,536 138,694 165,290 2,052,628
CDER 20,484 21,520 22,586 22,586 22,990 24,540 24,776 23,680 23,482 24,590 22,072 25,338 278,644
CBER 1,260 1,500 1,524 1,690 1,584 1,590 1,714 1,566 1,660 1,858 1,436 1,630 19,012
CDRH 241,456 277,536 260,000 273,488 217,308 240,148 256,648 270,224 342,680 317,040 248,060 305,184 3,249,772
CVM 7,452 7,317 8,316 10,149 10,599 11,274 13,362 12,837 12,690 14,439 10,617 12,276 131,328
OC 12,098 9,502 10,274 11,996 11,030 10,560 10,292 9,636 9,546 16,404 10,890 14,114 136,342
CTP 90 111 84 114 72 54 81 93 63 69 78 63 972
MWP 90 114 114 156 126 154 186 154 148 152 144 124 1,662
ACA 14 22 192 90 20 26 12 8 0 2 2 2 390
GDUFA 226 192 92 354 4,552 520 216 270 208 180 124 160 7,094
CFSAN 364 294 506 440 674 478 452 398 480 362 478 586 5,512
HC 390 620 728 728 890 954 1,562 1,286 1,036 1,138 1,140 1,128 11,670
Totals 438,892 495,440 540,850 531,853 409,969 437,756 515,719 467,328 546,819 550,770 433,735 525,895 5,895,026

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Page Last Updated: 08/06/2015
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