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Submission Statistics

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FDA ESG 2014-2024 Total Submission Statistics
  2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Totals
AERS 1,026,314 1,321,114 1,533,378 1,698,094 2,118,827 2,160,020 2,224,503 2,287,430 2,372,414 2,329,606 921,862 19,993,562
CDER 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 286,917 298,049 132,407 2,371,757
CBER 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 646,370 194,261 77,903 1,929,823
CDRH 812,443 1,478,524 2,032,767 1,921,871 2,247,286 2,774,852 2,960,441 3,774,725 4,851,638 4,110,044 1,802,796 28,767,387
CVM 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 85,983 106,500 57,874 802,283
OC 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 61,314 56,060 21,525 682,189
CTP 324 734 612 23,984 19,142 3,698 10,563 5,096 4,638 1,763 1,323 71,877
ACA 195 212 228 218 236 271 288 233 295 322 215 2,713
GDUFA 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 966 1,134 586 17,231
CFSAN 2,756 3,761 3,619 2,661 2,421 2,261 2,160 2,540 2,240 2,673 1,221 28,313
HC 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 37,634 38,039 15,541 276,295
ORA               57 58 27 13 155
Totals 2,113,020 3,100,970 3,895,669 4,055,342 4,841,844 5,428,492 5,728,006 7,258,031 8,350,467 7,138,478 3,033,266 54,943,585

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FDA ESG 2024 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 185,398 193,376 173,136 183,932 186,020               921,862
CDER 25,264 26,288 26,134 27,123 27,598               132,407
CBER 18,741 14,082 12,109 11,312 21,659               77,903
CDRH 340,896 363,556 317,844 348,358 432,142               1,802,796
CVM 12,085 10,607 10,779 11,937 12,466               57,874
OC 6,117 3,209 3,433 4,092 4,674               21,525
CTP 194 157 322 423 227               1,323
ACA 5 38 142 19 11               215
GDUFA 4 4 4 50 524               586
CFSAN 275 238 219 204 285               1,221
HC 3,111 3,060 2,937 3,187 3,246               15,541
ORA 2 0 10 1 0               13
Totals 592,092 614,615 547,069 590,638 688,852               3,033,266
 
FDA ESG 2024 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 185,398 193,376 173,136 183,932 186,020               921,862
CDER 50,528 52,576 52,268 54,246 55,196               264,814
CBER 37,482 28,164 24,218 22,624 43,318               155,806
CDRH 1,022,688 1,090,668 953,532 1,045,074 1,296,426               5,408,388
CVM 24,170 21,214 21,558 23,874 24,932               115,748
OC 12,234 6,418 6,866 8,184 9,348               43,050
CTP 388 314 644 846 454               2,646
ACA 10 76 284 38 22               430
GDUFA 8 8 8 100 1,048               1,172
CFSAN 275 238 219 204 285               1,221
HC 6,222 6,120 5,874 6,374 6,492               31,082
ORA 2 0 10 1 0               13
Totals 1,339,405 1,399,172 1,238,617 1,345,497 1,623,541               6,946,232

FDA ESG 2024 Monthly Total Traffic Statistics

  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 370,796 386,752 346,272 367,864 372,040               1,843,724
CDER 75,792 78,864 78,402 81,369 82,794               397,221
CBER 56,223 42,246 36,327 33,936 64,977               233,709
CDRH 1,363,584 1,454,224 1,271,376 1,393,432 1,728,568               7,211,184
CVM 36,255 31,821 32,337 35,811 37,398               173,622
OC 18,351 9,627 10,299 12,276 14,022               64,575
CTP 582 471 966 1,269 681               3,969
ACA 15 114 426 57 33               645
GDUFA 12 12 12 150 1,572               1,758
CFSAN 550 476 438 408 570               2,442
HC 9,333 9,180 8,811 9,561 9,738               46,623
ORA 4 0 20 2 0               26
Totals 1,931,497 2,013,787 1,785,686 1,936,135 2,312,393               9,979,498
FDA ESG 2023 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 201,379 188,228 202,526 181,068 198,262 198,480 188,832 203,874 186,292 199,836 200,539 180,290 2,329,606
CDER 21,089 22,110 27,118 23,105 25,884 25,716 23,640 27,030 24,609 26,684 26,235 24,829 298,049
CBER 20,825 17,530 25,459 15,241 16,684 14,248 13,085 12,829 11,348 18,519 16,274 12,219 194,261
CDRH 318,486 308,034 376,811 365,283 319,972 342,198 397,276 369,797 312,375 333,257 369,404 297,151 4,110,044
CVM 8,401 6,596 8,161 7,699 8,789 8,519 9,739 11,089 8,449 8,786 9,480 10,792 106,500
OC 5,830 4,472 4,279 3,012 3,254 3,603 3,122 3,545 3,474 6,799 6,536 8,134 56,060
CTP 118 194 182 105 122 141 139 150 102 148 157 205 1,763
ACA 3 25 247 28 0 3 1 1 5 0 1 8 322
GDUFA 11 19 35 11 556 132 31 21 263 19 19 17 1,134
CFSAN 137 173 336 180 234 205 252 240 186 212 299 219 2,673
HC 2,853 2,977 3,480 2,844 3,442 3,247 3,281 3,285 2,971 3,290 3,433 2,936 38,039
ORA 1 7 5 1 0 2 4 0 1 0 6 0 27
Totals 579,133 550,365 648,639 598,577 577,199 596,494 639,402 631,861 550,075 597,550 632,383 536,800 7,138,478
FDA ESG 2023 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 201,379 188,228 202,526 181,068 198,262 198,480 188,832 203,874 186,292 199,836 200,539 180,290 2,329,606
CDER 42,178 44,220 54,236 46,210 51,768 51,432 47,280 54,060 49,218 53,368 52,470 49,658 596,098
CBER 41,650 35,060 50,918 30,482 33,368 28,496 26,170 25,658 22,696 37,038 32,548 24,438 388,522
CDRH 955,458 924,102 1,130,433 1,095,849 959,916 1,026,594 1,191,828 1,109,391 937,125 999,771 1,108,212 891,453 12,330,132
CVM 16,802 13,192 16,322 15,398 17,578 17,038 19,478 22,178 16,898 17,572 18,960 21,584 213,000
OC 11,660 8,944 8,558 6,024 6,508 7,206 6,244 7,090 6,948 13,598 13,072 16,268 112,120
CTP 236 388 364 210 244 282 278 300 204 296 314 410 3,526
ACA 6 50 494 56 0 6 2 2 10 0 2 16 644
GDUFA 22 38 70 22 1,112 264 62 42 526 38 38 34 2,268
CFSAN 137 173 336 180 234 205 252 240 186 212 299 219 2,673
HC 5,706 5,954 6,960 5,688 6,884 6,494 6,562 6,570 5,942 6,580 6,866 5,872 76,078
ORA 1 7 5 1 0 2 4 0 1 0 6 0 27
Totals 1,275,235 1,220,356 1,471,222 1,381,188 1,275,874 1,336,499 1,486,992 1,429,405 1,226,046 1,328,309 1,433,326 1,190,242 16,054,694

FDA ESG 2023 Monthly Total Traffic Statistics

  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 402,758 376,456 405,052 362,136 396,524 396,960 377,664 407,748 372,584 399,672 401,078 360,580 4,659,212
CDER 63,267 66,330 81,354 69,315 77,652 77,148 70,920 81,090 73,827 80,052 78,705 74,487 894,147
CBER 62,475 52,590 76,377 45,723 50,052 42,744 39,255 38,487 34,044 55,557 48,822 36,657 582,783
CDRH 1,273,944 1,232,136 1,507,244 1,461,132 1,279,888 1,368,792 1,589,104 1,479,188 1,249,500 1,333,028 1,477,616 1,188,604 16,440,176
CVM 25,203 19,788 24,483 23,097 26,367 25,557 29,217 33,267 25,347 26,358 28,440 32,376 319,500
OC 17,490 13,416 12,837 9,036 9,762 10,809 9,366 10,635 10,422 20,397 19,608 24,402 168,180
CTP 354 582 546 315 366 423 417 450 306 444 471 615 5,289
ACA 9 75 741 84 0 9 3 3 15 0 3 24 966
GDUFA 33 57 105 33 1,668 396 93 63 789 57 57 51 3,402
CFSAN 274 346 672 360 468 410 504 480 372 424 598 438 5,346
HC 8,559 8,931 10,440 8,532 10,326 9,741 9,843 9,855 8,913 9,870 10,299 8,808 114,117
ORA 2 14 10 2 0 4 8 0 2 0 12 0 54
Totals 1,854,368 1,770,721 2,119,861 1,979,765 1,853,073 1,932,993 2,126,394 2,061,266 1,776,121 1,925,859 2,065,709 1,727,042 23,193,172
 

 
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