For Industry

Submission Statistics

FDA ESG 2006-2016 Total Submission Statistics
  2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Totals
AERS 55,156 159,562 252,614 300,672 472,142 557,917 717,345 876,475 1,026,314 1,321,114 1,047,932 6,787,243
CDER 1,639 11,175 24,797 45,510 69,739 93,503 107,681 124,232 139,322 159,515 110,043 887,156
CBER 294 1,504 2,557 4,483 5,588 6,397 6,927 8,412 9,506 11,294 10,867 67,829
CDRH 1,575 1,527 4,619 21,296 119,087 280,312 462,316 666,927 812,443 1,478,524 1,159,999 5,008,625
CVM   288 843 859 945 17,932 35,429 40,241 43,776 50,738 42,276 233,327
OC     188 16,275 48,232 55,676 64,285 65,430 68,171 60,943 34,040 413,240
CTP       5 223 348 642 1,237 324 734 358 3,871
MWP         1,138 2,530 2,499 737 831 1,863 793 10,391
ACA             62 207 195 212 221 897
GDUFA             2,771 2,926 3,547 2,906 1,501 13,651
CFSAN             458 4,220 2,756 3,761 2,698 13,893
HC               324 5,835 9,366 10,484 26,009
Totals 58,664 174,056 285,618 389,100 717,094 1,014,615 1,400,415 1,791,368 2,113,020 3,100,970 2,421,212 13,466,132
FDA ESG 2016 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 131,928 181,075 124,552 118,835 123,781 123,487 119,245 125,029         1,047,932
CDER 11,836 14,283 15,033 14,046 14,088 14,537 12,256 13,964         110,043
CBER 909 1,146 1,461 1,459 1,321 1,418 1,510 1,643         10,867
CDRH 102,904 105,441 121,011 144,773 129,037 146,535 179,350 230,948         1,159,999
CVM 3,836 3,904 4,836 5,435 6,498 6,062 5,163 6,542         42,276
OC 4,396 4,221 4,424 3,920 4,250 4,452 4,015 4,362         34,040
CTP 22 96 21 22 40 67 26 64         358
MWP 147 369 195 82 0 0 0 0         793
ACA 6 7 128 60 14 2 3 1         221
GDUFA 14 21 21 36 1,115 199 59 36         1,501
CFSAN 241 321 313 307 470 517 327 202         2,698
HC 976 1,224 1,443 1,336 1,244 1,465 1,389 1,407         10,484
Totals 257,215 312,108 273,438 290,311 281,858 298,741 323,343 384,198 0 0 0 0 2,421,212
FDA ESG 2016 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 131,928 181,075 124,552 118,835 123,781 123,487 119,245 125,029         1,047,932
CDER 11,836 14,283 15,033 14,046 14,088 29,074 24,512 27,928         150,800
CBER 909 1,146 1,461 1,459 1,321 1,418 1,510 1,643         10,867
CDRH 308,712 316,323 363,033 434,319 387,111 439,605 538,050 692,844         3,479,997
CVM 7,672 7,808 9,672 10,870 12,996 12,124 10,326 13,084         84,552
OC 4,396 4,221 4,424 3,920 4,250 4,452 4,015 4,362         34,040
CTP 44 192 42 44 80 134 52 128         716
MWP 147 369 195 82 0 0 0 0         793
ACA 6 7 128 60 14 2 3 1         221
GDUFA 14 21 21 36 1,115 199 59 36         1,501
CFSAN 241 321 313 307 470 517 327 202         2,698
HC 976 1,224 1,443 1,336 1,244 1,465 2,778 2,814         13,280
Totals 466,881 526,990 520,317 585,314 546,470 612,477 700,877 868,071 0 0 0 0 4,827,397
FDA ESG 2016 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 263,856 362,150 249,104 237,670 247,562 246,974 238,490 250,058         2,095,864
CDER 23,672 28,566 30,066 28,092 28,176 43,611 36,768 41,892         260,843
CBER 1,818 2,292 2,922 2,918 2,642 2,836 3,020 3,286         21,734
CDRH 411,616 421,764 484,044 579,092 516,148 586,140 717,400 923,792         4,639,996
CVM 11,508 11,712 14,508 16,305 19,494 18,186 15,489 19,626         126,828
OC 8,792 8,442 8,848 7,840 8,500 8,904 8,030 8,724         68,080
CTP 66 288 63 66 120 201 78 192         1,074
MWP 294 738 390 164 0 0 0 0         1,586
ACA 12 14 256 120 28 4 6 2         442
GDUFA 28 42 42 72 2,230 398 118 72         3,002
CFSAN 482 642 626 614 940 1,034 654 404         5,396
HC 1,952 2,448 2,886 2,672 2,488 2,930 4,167 4,221         23,764
Totals 724,096 839,098 793,755 875,625 828,328 911,218 1,024,220 1,252,269 0 0 0 0 7,248,609
FDA ESG 2015 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 82,917 160,010 110,496 93,227 84,451 96,088 108,442 121,632 125,138 119,059 100,956 118,698 1,321,114
CDER 11,232 12,242 13,696 13,586 12,938 13,513 14,171 12,777 13,939 13,779 12,948 14,694 159,515
CBER 819 753 858 865 807 925 1,072 956 945 1,092 1,070 1,132 11,294
CDRH 70,932 71,922 76,133 85,850 72,520 107,745 131,966 192,085 205,481 224,725 126,921 112,244 1,478,524
CVM 3,129 3,286 3,554 4,308 4,435 4,758 4,920 4,343 5,792 4,366 3,913 3,934 50,738
OC 5,382 4,648 4,708 5,192 4,625 5,307 4,368 4,211 4,376 6,374 5,135 6,617 60,943
CTP 20 71 17 81 141 32 32 43 59 103 76 59 734
MWP 92 83 101 133 181 132 95 87 347 229 211 172 1,863
ACA 4 18 118 54 12 1 2 0 1 0 0 2 212
GDUFA 89 79 97 78 2,127 182 67 40 36 36 33 42 2,906
CFSAN 462 418 435 342 253 258 282 296 275 294 253 193 3,761
HC 724 630 753 651 706 708 1,125 804 734 804 866 861 9,366
Totals 175,802 254,160 210,966 204,367 183,196 229,649 266,542 337,274 357,123 370,861 252,382 258,648 3,100,970
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 96,088 108,442 121,632 125,138 119,059 100,956 118,698 1,321,121
CDER 11,232 12,242 13,696 13,586 12,938 13,513 14,171 12,777 13,939 13,779 12,948 14,694 159,515
CBER 819 753 858 865 807 925 1,072 956 945 1,092 1,070 1,132 11,294
CDRH 212,730 215,655 228,555 257,598 217,560 323,235 395,898 576,255 616,443 674,175 380,763 336,732 4,435,599
CVM 6,258 6,572 7,108 8,616 8,870 9,516 9,840 8,686 11,584 8,732 7,826 7,868 101,476
OC 5,380 4,650 4,706 5,194 4,625 5,307 4,368 4,211 4,376 6,374 5,135 6,617 60,943
CTP 40 142 34 162 282 64 64 86 118 206 152 118 1,468
MWP 92 83 101 133 181 132 95 87 347 229 211 172 1,863
ACA 4 18 118 54 12 1 2 0 1 0 0 2 212
GDUFA 89 79 97 78 2,127 182 67 40 36 36 33 42 2,906
CFSAN 462 418 435 342 253 88 88 296 275 294 253 193 3,397
HC 724 630 753 651 706 708 1,125 804 734 804 866 861 9,366
Totals 320,751 401,250 366,960 380,508 332,812 449,759 535,232 725,830 773,936 824,780 510,213 487,129 6,109,160
FDA ESG 2015 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 165,842 320,016 220,998 186,458 168,902 192,176 216,884 243,264 250,276 238,118 201,912 237,396 2,642,242
CDER 22,464 24,484 27,392 27,172 25,876 27,026 28,342 25,554 27,878 27,558 25,896 29,388 319,030
CBER 1,638 1,506 1,716 1,730 1,614 1,850 2,144 1,912 1,890 2,184 2,140 2,264 22,588
CDRH 283,640 287,540 304,740 343,464 290,080 430,980 527,864 768,340 821,924 898,900 507,684 448,976 5,914,132
CVM 9,387 9,858 10,662 12,924 13,305 14,274 14,760 13,029 17,376 13,098 11,739 11,802 152,214
OC 10,760 9,300 9,412 10,388 9,250 10,614 8,736 8,422 8,752 12,748 10,270 13,234 121,886
CTP 60 213 51 243 423 96 96 129 177 309 228 177 2,202
MWP 184 166 202 266 362 264 190 174 694 458 422 344 3,726
ACA 8 36 236 108 24 2 4 0 2 0 0 4 424
GDUFA 178 158 194 156 4,254 364 134 80 72 72 66 84 5,812
CFSAN 924 836 870 684 506 176 176 592 550 588 506 386 6,794
HC 1,448 1,260 1,506 1,302 1,412 1,416 2,250 1,608 1,468 1,608 1,732 1,722 18,732
Totals 496,533 655,373 577,979 584,895 516,008 679,238 801,580 1,063,104 1,131,059 1,195,641 762,595 745,777 9,209,782

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