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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
FDA ESG 2016 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 131,928 181,075 124,552 118,835 123,781 123,487 119,245 125,029 120,565 124,496 118,465 121,920 1,533,378
CDER 11,836 14,283 15,033 14,046 14,088 14,537 12,256 13,964 14,018 13,246 13,705 14,920 165,932
CBER 909 1,146 1,461 1,459 1,321 1,418 1,510 1,643 1,706 1,770 1,902 4,033 20,278
CDRH 102,904 105,441 121,011 144,773 129,037 146,535 179,350 230,948 359,327 235,412 135,945 142,084 2,032,767
CVM 3,836 3,904 4,836 5,435 6,498 6,062 5,163 6,542 5,544 5,531 5,585 4,468 63,404
OC 4,396 4,221 4,424 3,920 4,250 4,452 4,015 4,362 4,352 6,455 5,413 6,257 56,517
CTP 22 96 21 22 40 67 26 64 45 35 36 138 612
MWP 147 369 195 82 0 0 0 0 0 0 0 0 793
ACA 6 7 128 60 14 2 3 1 1 3 3 0 228
GDUFA 14 21 21 36 1,115 199 59 36 40 35 37 31 1,644
CFSAN 241 321 313 307 470 517 327 202 181 205 250 285 3,619
HC 976 1,224 1,443 1,336 1,244 1,465 1,389 1,407 1,393 1,355 1,596 1,669 16,497
Totals 257,215 312,108 273,438 290,311 281,858 298,741 323,343 384,198 507,172 388,543 282,937 295,805 3,895,669
FDA ESG 2016 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 131,928 181,075 124,552 118,835 123,781 123,487 119,245 125,029 120,565 124,496 118,465 121,920 1,533,378
CDER 11,836 14,283 15,033 14,046 14,088 29,074 24,512 27,928 28,036 26,492 27,410 29,840 262,578
CBER 909 1,146 1,461 1,459 1,321 1,418 1,510 1,643 1,706 1,770 1,902 4,033 20,278
CDRH 308,712 316,323 363,033 434,319 387,111 439,605 538,050 692,844 1,077,981 706,236 407,835 426,252 6,098,301
CVM 7,672 7,808 9,672 10,870 12,996 12,124 10,326 13,084 11,088 11,062 11,170 8,936 126,808
OC 8,792 8,442 8,848 7,840 8,500 8,904 8,030 8,724 8,704 12,910 10,826 12,514 113,034
CTP 44 192 42 44 80 134 52 128 90 70 72 276 1,224
MWP 147 369 195 82 0 0 0 0 0 0 0 0 793
ACA 6 7 128 60 14 2 3 1 1 3 3 0 228
GDUFA 14 21 21 36 1,115 199 59 36 40 35 37 31 1,644
CFSAN 241 321 313 307 470 517 327 202 181 205 250 285 3,619
HC 976 1,224 1,443 1,336 1,244 1,465 2,778 2,814 2,786 2,710 3,192 3,338 25,306
Totals 471,277 531,211 524,741 589,234 550,720 616,929 704,892 872,433 1,251,178 885,989 581,162 607,425 8,187,191
FDA ESG 2016 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 263,856 362,150 249,104 237,670 247,562 246,974 238,490 250,058 241,130 248,992 236,930 243,840 3,066,756
CDER 23,672 28,566 30,066 28,092 28,176 43,611 36,768 41,892 42,054 39,738 41,115 44,760 428,510
CBER 1,818 2,292 2,922 2,918 2,642 2,836 3,020 3,286 3,412 3,540 3,804 8,066 40,556
CDRH 411,616 421,764 484,044 579,092 516,148 586,140 717,400 923,792 1,437,308 941,648 543,780 568,336 8,131,068
CVM 11,508 11,712 14,508 16,305 19,494 18,186 15,489 19,626 16,632 16,593 16,755 13,404 190,212
OC 13,188 12,663 13,272 11,760 12,750 13,356 12,045 13,086 13,056 19,365 16,239 18,771 169,551
CTP 66 288 63 66 120 201 78 192 135 105 108 414 1,836
MWP 294 738 390 164 0 0 0 0 0 0 0 0 1,586
ACA 12 14 256 120 28 4 6 2 2 6 6 0 456
GDUFA 28 42 42 72 2,230 398 118 72 80 70 74 62 3,288
CFSAN 482 642 626 614 940 1,034 654 404 362 410 500 570 7,238
HC 1,952 2,448 2,886 2,672 2,488 2,930 4,167 4,221 4,179 4,065 4,788 5,007 41,803
Totals 728,492 843,319 798,179 879,545 832,578 915,670 1,028,235 1,256,631 1,758,350 1,274,532 864,099 903,230 12,082,860
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
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
FDA ESG 2013 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 93,365 61,638 63,671 66,882 65,284 64,807 68,039 69,495 67,313 111,469 72,206 72,306 876,475
CDER 9,095 9,657 10,199 10,914 11,212 10,322 10,635 10,291 9,807 11,221 9,944 10,935 124,232
CBER 619 566 654 680 736 667 791 764 780 811 658 686 8,412
CDRH 45,044 45,463 42,220 59,465 51,914 61,173 63,190 65,249 53,316 68,704 52,942 58,247 666,927
CVM 2,403 3,608 2,612 4,396 3,678 4,396 3,254 3,012 3,507 3,401 3,125 2,849 40,241
OC 6,931 4,532 4,400 4,785 5,154 4,699 4,935 5,377 4,405 6,808 5,860 7,544 65,430
CTP 203 49 38 92 257 157 126 109 126 20 6 54 1,237
MWP 61 54 44 55 56 82 57 57 56 75 79 61 737
ACA 0 9 47 67 33 11 20 4 6 1 6 3 207
GDUFA 0 123 100 71 1,952 126 73 85 117 98 95 86 2,926
CFSAN 320 232 234 237 180 129 143 178 211 1,621 313 163 4,220
HC                     154 170 324
Totals 158,041 125,931 124,219 147,644 140,456 146,569 151,263 154,621 139,644 204,229 145,388 153,104 1,791,368
FDA ESG 2013 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 93,365 61,638 63,671 66,882 65,284 64,807 68,039 69,495 67,313 111,469 72,206 72,306 876,475
CDER 9,095 9,657 10,199 10,914 11,212 10,322 10,635 10,291 9,807 11,221 9,944 10,935 124,232
CBER 619 566 654 680 736 667 791 764 780 811 658 686 8,412
CDRH 135,132 136,389 126,660 178,395 155,742 183,519 189,570 195,747 159,948 206,112 158,826 174,741 2,000,781
CVM 4,806 7,216 5,224 8,792 7,356 8,792 6,508 6,024 7,014 6,802 6,250 5,698 80,482
OC 6,931 4,532 4,400 4,785 5,154 4,699 4,935 5,377 4,405 6,808 5,860 7,544 65,430
CTP 609 147 114 276 771 471 378 218 252 40 12 108 3,396
MWP 61 54 44 55 56 82 57 57 56 75 79 61 737
ACA 0 9 47 67 33 11 20 4 6 1 6 3 207
GDUFA 0 123 100 71 1,952 126 73 85 117 98 95 86 2,926
CFSAN 320 232 234 237 180 129 143 178 211 1,621 313 163 4,220
HC                     154 170 324
Totals 250,938 220,563 211,347 271,154 248,476 273,625 281,149 288,240 249,909 345,058 254,403 272,501 3,167,622
FDA ESG 2013 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 186,730 123,276 127,342 133,764 130,568 129,614 136,078 138,990 134,626 222,938 144,412 144,612 1,752,950
CDER 18,190 19,314 20,398 21,828 22,424 20,644 21,270 20,582 19,614 22,442 19,888 21,870 248,464
CBER 1,236 1,132 1,308 1,360 1,472 1,334 1,582 1,528 1,560 1,622 1,316 1,372 16,824
CDRH 180,176 181,852 168,880 237,860 207,656 244,692 252,760 260,996 213,264 274,816 211,768 232,988 2,667,708
CVM 7,209 10,824 7,836 13,188 11,034 13,188 9,762 9,036 10,521 10,203 9,375 8,547 120,723
OC 13,862 9,064 8,800 9,570 10,308 9,398 9,870 10,754 8,810 13,616 11,720 15,088 130,860
CTP 812 196 152 368 1,028 628 504 327 378 60 18 162 4,633
MWP 122 108 88 110 112 164 114 114 112 150 158 122 1,474
ACA 0 18 94 134 66 22 40 8 12 2 12 6 414
GDUFA 0 246 200 142 3,904 252 146 170 234 196 190 172 5,852
CFSAN> 640 464 0 474 360 258 286 356 422 3,242 626 326 7,454
HC                     308 340 648
Totals 408,979 346,494 335,098 418,798 388,932 420,194 432,412 442,861 389,553 549,287 399,791 425,605 4,958,004
FDA ESG 2012 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 68,102 52,381 52,626 51,151 57,520 54,137 53,453 66,626 61,277 77,909 65,465 56,698 717,345
CDER 7,455 8,054 9,465 8,588 9,250 8,815 8,324 10,366 9,079 8,971 10,245 9,069 107,681
CBER 470 518 595 594 607 563 636 621 534 598 573 618 6,927
CDRH 36,669 38,843 53,236 41,056 35,871 34,657 38,248 37,727 33,208 40,840 35,545 36,416 462,316
CVM 3,376 4,048 2,659 2,633 2,905 2,854 3,126 3,690 2,345 2,632 2,631 2,530 35,429
OC 6,649 4,804 5,101 5,023 5,093 5,102 4,687 5,906 4,790 6,206 5,450 5,474 64,285
CTP 79 7 3 37 131 45 25 64 102 27 35 87 642
MWP 272 344 616 287 >586 56 44 58 42 >56 75 63 2,499
ACA                 32 21 6 3 62
GDUFA                 36 633 1409 93 2,771
CFSAN                     260 198 458
Totals 123,072 108,999 124,301 109,369 111,963 106,229 108,543 125,058 111,445 137,893 121,694 111,849 1,400,415
FDA ESG 2011 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 47,160 37,282 47,739 42,665 45,939 49,654 40,094 54,154 40,695 50,217 56,387 45,931 557,917
CDER 6,320 7,248 8,213 7,649 8,008 8,251 7,686 8,364 7,999 7,858 7,902 8,005 93,503
CBER 396 476 605 466 536 574 534 611 533 530 562 574 6,937
CDRH 20,194 13,374 17,275 21,680 19,567 20,075 27,478 24,501 26,522 32,546 29,427 27,673 280,312
CVM 280 444 562 516 714 674 565 2,920 3,498 3,240 2,827 1,692 17,932
OC 5,758 4,041 4,638 4,380 4,645 5,726 4,651 4,616 3,974 3,861 4,451 4,935 55,676
CTP 26 12 24 6 10 24 7 3 17 18 136 65 348
MWP 160 171 183 164 190 165 112 200 191 266 354 374 2,530
Totals 80,294 63,048 79,239 77,526 79,609 85,143 81,127 95,369 83,429 98,536 102,046 89,249 1,014,615
FDA ESG 2010 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 28,801 28,889 31,713 27,601 27,305 38,697 67,085 47,587 42,622 35,510 40,007 57,045 472,142
CDER 4,171 4,660 5,798 5,581 5,639 6,136 5,696 6,195 5,980 6,279 6,485 7,119 69,739
CBER 361 427 535 457 399 555 502 477 449 476 441 509 5,588
CDRH 3,465 6,108 6,904 7,153 6,217 8,183 13,590 12,097 10,620 18,096 11,905 14,749 119,087
CVM 78 106 73 93 59 90 67 77 51 67 74 110 945
OC 3,904 3,906 4,114 3,649 3,745 5,767 4,301 4,499 3,519 3,415 3,457 4,766 48,232
CTP 1 23 6 14 3 61 20 17 20 9 6 43 223
MWP         106 157 106 176 130 119 114 230 1,138
Totals 40,061 43,309 49,143 44,548 43,473 59,646 91,367 71,125 63,391 63,971 62,489 84,571 717,094
FDA ESG 2009 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 19,261 21,031 26,581 22,152 22,569 26,240 24,224 29,097 30,467 25,240 25,480 28,330 300,672
CDER 2,268 2,998 3,235 3,408 3,493 3,692 3,989 4,075 4,182 4,758 4,552 4,860 45,510
CBER 257 261 341 338 290 362 363 352 365 479 517 558 4,483
CDRH 700 812 1,642 1,554 1,361 1,345 1,694 1,339 2,448 2,529 3,299 2,573 21,296
CVM 60 73 103 103 70 70 96 68 58 46 55 57 859
OC 63 70 102 96 85 840 969 1,416 1,852 2,640 2,971 5,171 16,275
CTP                       5 5
Totals 22,609 25,245 32,004 27,651 27,868 32,549 31,335 36,347 39,372 35,692 36,874 41,554 389,100
FDA ESG 2008 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 15,325 17,882 25,760 21,631 18,703 21,966 19,359 21,527 22,691 20,001 19,170 28,599 252,614
CDER 1,397 1,720 1,644 1,695 1,747 1,783 2,121 2,328 2,375 2,718 2,413 2,856 24,797
CBER 153 195 168 203 194 220 301 201 223 239 177 283 2,557
CDRH 115 147 144 212 246 279 257 387 451 939 403 1,039 4,619
CVM 62 64 70 78 63 101 83 90 41 69 50 72 843
OC             2 15 18 24 27 102 188
Totals 17,052 20,008 27,786 23,819 20,953 24,349 22,123 24,548 25,799 23,990 22,240 32,951 285,618
FDA ESG 2007 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 9,576 9,948 12,158 14,696 12,917 15,177 12,546 12,906 14,925 14,810 13,568 16,335 159,562
CDER 457 600 650 785 1,009 950 880 1,132 930 1,212 1,258 1,312 11,175
CBER 68 58 85 102 101 106 119 193 149 179 181 163 1,504
CDRH 176 108 127 102 75 138 80 205 267 118 70 61 1,527
CVM             45 58 35 55 46 49 288
OC                          
Totals 10,277 10,714 13,020 15,685 14,102 16,371 13,670 14,494 16,306 16,374 15,123 17,920 174,056
FDA ESG 2006 Monthly Submission Statistics
  May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 9,109 6,188 5,155 6,408 5,621 6,393 7,759 8,523 55,156
CDER 20 54 44 119 207 283 411 501 1,639
CBER 6 9 19 36 56 49 61 58 294
CDRH 153 312 272 198 95 237 172 136 1,575
CVM                  
OC                  
Totals 9,288 6,563 5,490 6,761 5,979 6,962 8,403 9,218 58,664

 

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