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 1,823,723 25,265,299 CDER 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 286,917 298,049 310,433 319,828 237,881 3,107,492 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 65,179 2,159,192 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 4,748,338 40,892,764 CVM 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 85,983 106,500 132,770 130,311 107,455 1,114,945 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 36,263 800,821 CTP 324 734 612 23,984 19,142 3,698 10,563 5,096 4,638 1,763 3,113 275 379 74,321 ACA 195 212 228 218 236 271 288 233 295 322 220 316 255 3,289 GDUFA 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 966 1,134 731 694 604 18,674 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 14,036 30,875 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 44,191 380,126 ORA * 57 58 27 15 N/A N/A 157 OII * 0 10 17 27 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 7,078,321 73,877,207
Note: * On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency.
FDA ESG 2026 Monthly Submission Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 173,506 188,373 170,260 205,810 169,886 185,431 180,535 179,548 190,862 179,512 1,823,723 CDER 22,948 23,779 26,124 24,527 22,222 23,763 23,870 22,646 24,094 23,908 237,881 CBER 6,201 6,578 7,394 6,502 6,314 6,331 6,528 6,065 6,221 7,045 65,179 CDRH 410,886 397,919 444,109 453,177 445,414 480,273 495,283 584,379 567,604 469,294 4,748,338 CVM 9,142 9,075 11,244 11,265 10,922 11,491 11,589 11,505 10,591 10,631 107,455 OC 5,281 2,956 4,001 3,393 3,280 3,354 3,230 3,066 3,154 4,548 36,263 CTP 28 25 27 31 18 182 16 18 8 26 379 ACA 2 39 171 36 1 0 0 1 0 5 255 GDUFA 8 6 12 15 427 56 10 20 24 26 604 HFP 1,332 1,129 1,309 1,227 1,264 1,120 1,615 1,623 1,693 1,724 14,036 HC 3,389 3,576 4,372 4,319 4,257 4,811 5,021 4,536 4,926 4,984 44,191 OII 0 1 0 1 0 1 0 11 3 0 17 Totals 632,723 633,456 669,023 710,303 664,005 716,813 727,697 813,418 809,180 701,703 7,078,321
FDA ESG 2026 Monthly Acknowledgement Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 180,861 195,919 180,340 214,873 177,272 192,926 189,789 187,381 197,605 184,318 1,901,284 CDER 66,325 65,612 72,137 67,122 60,786 64,851 65,256 61,617 65,661 64,986 654,353 CBER 14,993 15,490 17,273 15,168 14,619 14,685 15,228 14,163 14,428 16,326 152,373 CDRH 1,349,520 1,209,267 1,364,192 1,394,686 1,362,730 1,500,700 1,549,339 1,777,176 1,775,567 1,443,746 14,726,923 CVM 19,978 19,762 24,486 24,100 23,187 24,518 24,655 24,442 22,692 22,791 230,611 OC 15,556 7,894 10,358 8,993 8,713 8,696 8,595 8,163 8,387 12,570 97,925 CTP 71 61 60 69 44 570 48 54 24 77 1,078 ACA 6 113 482 137 3 0 0 3 0 15 759 GDUFA 23 18 32 45 1,208 168 31 58 72 77 1,732 HFP 2,898 2,258 2,618 2,454 2,528 2,240 3,230 3,246 3,386 3,450 28,308 HC 9,724 9,985 12,225 12,056 11,906 13,583 14,105 12,836 13,947 14,031 124,398 OII 0 2 0 2 0 2 0 33 9 0 48 Totals 1,659,955 1,526,381 1,684,203 1,739,705 1,662,996 1,822,939 1,870,276 2,089,172 2,101,778 1,762,387 17,919,792
FDA ESG 2026 Monthly Total Traffic Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 354,367 384,292 350,600 420,683 347,158 378,357 370,324 366,929 388,467 363,830 3,725,007 CDER 89,273 89,391 98,261 91,649 83,008 88,614 89,126 84,263 89,755 88,894 892,234 CBER 21,194 22,068 24,667 21,670 20,933 21,016 21,756 20,228 20,649 23,371 217,552 CDRH 1,760,406 1,607,186 1,808,301 1,847,863 1,808,144 1,980,973 2,044,622 2,361,555 2,343,171 1,913,040 19,475,261 CVM 29,120 28,837 35,730 35,365 34,109 36,009 36,244 35,947 33,283 33,422 338,066 OC 20,837 10,850 14,359 12,386 11,993 12,050 11,825 11,229 11,541 17,118 134,188 CTP 99 86 87 100 62 752 64 72 32 103 1,457 ACA 8 152 653 173 4 0 0 4 0 20 1,014 GDUFA 31 24 44 60 1,635 224 41 78 96 103 2,336 HFP 4,230 3,387 3,927 3,681 3,792 3,360 4,845 4,869 5,079 5,174 42,344 HC 13,113 13,561 16,597 16,375 16,163 18,394 19,126 17,372 18,873 19,015 168,589 OII 0 3 0 3 0 3 0 44 12 0 65 Totals 2,292,678 2,159,837 2,353,226 2,450,008 2,327,001 2,539,752 2,597,973 2,902,590 2,910,958 2,464,090 24,998,113
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:
11/06/2026
