FDA ESG 2014-2026 Total Submission Statistics 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 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 2,166,479 2,203,397 1,093,266 24,534,842 CDER 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 286,917 298,049 310,433 319,828 143,363 3,012,974 CBER 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 646,370 194,261 144,960 97,133 39,320 2,133,333 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 4,515,331 4,664,504 2,631,778 38,776,204 CVM 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 85,983 106,500 132,770 130,311 63,139 1,070,629 OC 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 61,314 56,060 56,877 47,017 22,265 786,823 CTP 324 734 612 23,984 19,142 3,698 10,563 5,096 4,638 1,763 3,113 275 311 74,253 ACA 195 212 228 218 236 271 288 233 295 322 220 316 249 3,283 GDUFA 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 966 1,134 731 694 524 18,594 CFSAN * 2,756 3,761 3,619 2,661 2,421 2,261 2,160 2,540 2,240 2,673 2,133 N/A N/A 29,225 HFP * 2,878 13,961 7,381 24,220 HC 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 37,634 38,039 36,231 38,950 24,724 360,659 ORA * 57 58 27 15 N/A N/A 157 OII * 0 10 3 13 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 7,372,171 7,516,396 4,026,323 70,825,209
Note: * On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency.
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FDA ESG 2026 Monthly Submission Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 173,506 188,373 170,260 205,810 169,886 185,431 1,093,266 CDER 22,948 23,779 26,124 24,527 22,222 23,763 143,363 CBER 6,201 6,578 7,394 6,502 6,314 6,331 39,320 CDRH 410,886 397,919 444,109 453,177 445,414 480,273 2,631,778 CVM 9,142 9,075 11,244 11,265 10,922 11,491 63,139 OC 5,281 2,956 4,001 3,393 3,280 3,354 22,265 CTP 28 25 27 31 18 182 311 ACA 2 39 171 36 1 0 249 GDUFA 8 6 12 15 427 56 524 HFP 1,332 1,129 1,309 1,227 1,264 1,120 7,381 HC 3,389 3,576 4,372 4,319 4,257 4,811 24,724 OII 0 1 0 1 0 1 3 Totals 632,723 633,456 669,023 710,303 664,005 716,813 4,026,323
FDA ESG 2026 Monthly Acknowledgement Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 181,061 196,238 180,560 215,322 177,605 193,023 1,143,809 CDER 66,348 65,631 72,158 67,159 60,791 64,867 396,954 CBER 14,997 15,493 17,281 15,204 14,631 14,686 92,292 CDRH 1,350,083 1,210,248 1,366,751 1,397,673 1,363,742 1,513,613 8,202,110 CVM 19,980 19,763 24,489 24,103 23,187 24,526 136,048 OC 15,558 7,895 10,358 8,993 8,785 8,696 60,285 CTP 71 61 60 69 44 570 875 ACA 6 113 482 137 3 0 741 GDUFA 23 18 32 45 1,208 168 1,494 HFP 2,900 2,258 2,622 2,454 2,528 2,240 15,002 HC 9,726 9,985 12,225 12,056 11,906 13,583 69,481 OII 0 2 0 2 0 2 6 Totals 1,660,753 1,527,705 1,687,018 1,743,217 1,664,430 1,835,974 10,119,097
FDA ESG 2026 Monthly Total Traffic Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 354,567 384,611 350,820 421,132 347,491 378,454 2,237,075 CDER 89,296 89,410 98,282 91,686 83,013 88,630 540,317 CBER 21,198 22,071 24,675 21,706 20,945 21,017 131,612 CDRH 1,760,969 1,608,167 1,810,860 1,850,850 1,809,156 1,993,886 10,833,888 CVM 29,122 28,838 35,733 35,368 34,109 36,017 199,187 OC 20,839 10,851 14,359 12,386 12,065 12,050 82,550 CTP 99 86 87 100 62 752 1,186 ACA 8 152 653 173 4 0 990 GDUFA 31 24 44 60 1,635 224 2,018 HFP 4,232 3,387 3,931 3,681 3,792 3,360 22,383 HC 13,115 13,561 16,597 16,375 16,163 18,394 94,205 OII 0 3 0 3 0 3 9 Totals 2,293,476 2,161,161 2,356,041 2,453,520 2,328,435 2,552,787 14,145,420
FDA ESG 2025 Monthly Submission Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 178,177 169,355 175,246 175,263 179,902 177,560 210,503 211,890 182,420 182,292 179,525 181,264 2,203,397 CDER 23,728 24,346 27,442 27,628 26,697 27,058 30,721 26,027 27,238 28,316 23,696 26,931 319,828 CBER 8,588 8,065 8,759 9,027 7,875 6,966 8,123 7,105 8,335 8,780 7,621 7,889 97,133 CDRH 380,849 326,865 389,580 363,504 328,203 390,380 482,180 399,452 410,826 425,314 374,168 393,183 4,664,504 CVM 9,640 9,687 11,072 13,492 11,149 11,066 11,841 10,446 11,438 10,791 9,631 10,058 130,311 OC 4,719 3,224 3,512 3,569 3,335 3,412 3,281 2,733 3,045 4,607 4,814 6,766 47,017 CTP 90 13 14 8 23 18 25 8 23 14 11 28 275 ACA 4 22 218 34 21 1 9 2 0 5 0 0 316 GDUFA 5 10 5 15 505 43 21 9 34 15 10 22 694 HFP 972 814 899 1,820 1,003 981 1,496 1,104 1,238 1,196 1,151 1,287 13,961 HC 2,772 2,869 3,107 3,253 3,056 3,135 3,554 3,262 3,331 3,788 3,344 3,479 38,950 OII 0 0 0 2 1 0 3 2 0 0 1 1 10 Totals 609,544 545,270 619,854 597,613 561,770 620,620 751,757 662,040 647,928 665,118 603,972 630,908 7,516,396
FDA ESG 2025 Monthly Acknowledgement Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 178,177 169,355 175,246 178,560 185,763 186,612 218,607 219,377 190,942 188,182 190,567 195,796 2,277,184 CDER 47,456 48,692 54,884 68,208 74,478 75,769 85,689 72,600 76,062 78,203 65,709 75,089 822,839 CBER 17,176 16,130 17,518 19,551 18,633 16,474 19,154 16,713 19,463 20,150 17,334 18,327 216,623 CDRH 1,142,547 980,595 1,168,740 1,260,280 1,306,531 1,165,358 1,418,895 1,167,642 1,230,244 1,287,001 1,143,918 1,215,641 14,487,392 CVM 19,280 19,374 22,144 31,001 25,337 23,340 27,657 22,296 24,293 23,561 20,437 28,193 286,913 OC 9,438 6,448 7,024 8,517 9,073 9,249 8,844 7,295 8,287 12,260 12,930 18,696 118,061 CTP 180 26 28 12 38 35 57 19 55 29 26 63 568 ACA 8 44 436 77 64 3 27 6 0 15 0 0 680 GDUFA 10 20 10 44 1,441 129 62 27 103 46 30 66 1,988 HFP 972 814 899 1,829 1,015 1,683 2,992 2,208 2,476 2,392 2,302 2,574 22,156 HC 5,544 5,738 6,214 8,009 8,459 8,720 9,865 9,069 9,180 10,568 9,286 9,688 100,340 OII 0 0 0 4 2 0 6 4 0 0 2 3 21 Totals 1,420,788 1,247,236 1,453,143 1,576,092 1,630,834 1,487,372 1,791,855 1,517,256 1,561,105 1,622,407 1,462,541 1,564,136 18,334,765
FDA ESG 2025 Monthly Total Traffic Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 356,354 338,710 350,492 353,823 365,665 364,172 429,110 431,267 373,362 370,474 370,092 377,060 4,480,581 CDER 71,184 73,038 82,326 95,836 101,175 102,827 116,410 98,627 103,300 106,519 89,405 102,020 1,142,667 CBER 25,764 24,195 26,277 28,578 26,508 23,440 27,277 23,818 27,798 28,930 24,955 26,216 313,756 CDRH 1,523,396 1,307,460 1,558,320 1,623,784 1,634,734 1,555,738 1,901,075 1,567,094 1,641,070 1,712,315 1,518,086 1,608,824 19,151,896 CVM 28,920 29,061 33,216 44,493 36,486 34,406 39,498 32,742 35,731 34,352 30,068 38,251 417,224 OC 14,157 9,672 10,536 12,086 12,408 12,661 12,125 10,028 11,332 16,867 17,744 25,462 165,078 CTP 270 39 42 20 61 53 82 27 78 43 37 91 843 ACA 12 66 654 111 85 4 36 8 0 20 0 0 996 GDUFA 15 30 15 59 1,946 172 83 36 137 61 40 88 2,682 HFP 1,944 1,628 1,798 3,649 2,018 2,664 4,488 3,312 3,714 3,588 3,453 3,861 36,117 HC 8,316 8,607 9,321 11,262 11,515 11,855 13,419 12,331 12,511 14,356 12,630 13,167 139,290 OII 0 0 0 6 3 0 9 6 0 0 3 4 31 Totals 2,030,332 1,792,506 2,072,997 2,173,707 2,192,604 2,107,992 2,543,612 2,179,296 2,209,033 2,287,525 2,066,513 2,195,044 25,851,161
Content current as of:
07/02/2026
