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 2,203,397 173,506 23,615,082 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 22,948 2,892,559 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 6,201 2,100,214 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 4,664,504 410,886 36,555,312 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 9,142 1,016,632 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 5,281 769,839 CTP 324 734 612 23,984 19,142 3,698 10,563 5,096 4,638 1,763 3,113 275 28 73,970 ACA 195 212 228 218 236 271 288 233 295 322 220 316 2 3,036 GDUFA 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 966 1,134 731 694 8 18,078 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 1,332 18,171 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 3,389 339,324 ORA * 57 58 27 15 N/A N/A 157 OII * 0 10 0 10 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 7,516,396 632,723 67,431,609
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 173,506 173,506 CDER 22,948 22,948 CBER 6,201 6,201 CDRH 410,886 410,886 CVM 9,142 9,142 OC 5,281 5,281 CTP 28 28 ACA 2 2 GDUFA 8 8 HFP 1,332 1,332 HC 3,389 3,389 OII 0 0 Totals 632,723 632,723
FDA ESG 2026 Monthly Acknowledgement Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 181,061 181,061 CDER 66,348 66,348 CBER 14,997 14,997 CDRH 1,350,083 1,350,083 CVM 19,980 19,980 OC 15,558 15,558 CTP 71 71 ACA 6 6 GDUFA 23 23 HFP 2,900 2,900 HC 9,726 9,726 OII 0 0 Totals 1,660,753 1,660,753
FDA ESG 2026 Monthly Total Traffic Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 354,567 354,567 CDER 89,296 89,296 CBER 21,198 21,198 CDRH 1,760,969 1,760,969 CVM 29,122 29,122 OC 20,839 20,839 CTP 99 99 ACA 8 8 GDUFA 31 31 HFP 4,232 4,232 HC 13,115 13,115 OII 0 0 Totals 2,293,476 2,293,476
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
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02/11/2026
