FDA ESG 2014-2025 Total Submission Statistics 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 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 2,022,133 23,260,312 CDER 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 286,917 298,049 310,433 292,897 2,842,680 CBER 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 646,370 194,261 144,960 89,244 2,086,124 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 4,271,321 35,751,243 CVM 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 85,983 106,500 132,770 120,253 997,432 OC 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 61,314 56,060 56,877 40,251 757,792 CTP 324 734 612 23,984 19,142 3,698 10,563 5,096 4,638 1,763 3,113 247 73,914 ACA 195 212 228 218 236 271 288 233 295 322 220 316 3,034 GDUFA 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 966 1,134 731 672 18,048 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 29,225 HFP * 2,878 12,674 15,552 HC 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 37,634 38,039 36,231 35,471 332,456 ORA * 57 58 27 15 N/A 157 OII * 0 9 9 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 6,885,488 66,167,978
Note: * On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency.
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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
FDA ESG 2024 Monthly Submission Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 177,351 185,763 173,140 178,600 184,799 160,796 199,105 176,653 172,791 210,376 171,817 175,288 2,166,479 CDER 23,998 25,031 26,127 26,252 27,526 24,579 27,432 26,148 26,078 27,188 24,880 25,194 310,433 CBER 18,099 13,481 12,109 10,972 21,647 8,146 10,184 10,053 8,824 11,985 10,385 9,075 144,960 CDRH 324,275 348,543 317,844 336,083 430,363 363,266 408,494 445,725 381,461 379,621 407,718 371,938 4,515,331 CVM 11,746 10,339 10,779 11,679 12,451 11,173 11,627 10,290 11,372 11,507 9,861 9,946 132,770 OC 5,944 3,099 3,433 3,883 4,669 3,583 4,287 4,127 3,492 6,592 5,463 8,305 56,877 CTP 191 153 322 413 227 274 300 283 217 209 215 309 3,113 ACA 3 37 142 19 11 4 1 1 2 220 GDUFA 4 3 7 30 520 60 16 16 13 44 10 8 731 CFSAN 270 224 219 197 284 215 246 208 270 2,133 HFP 998 1,007 873 2,878 HC 2,979 2,914 2,937 3,081 3,240 2,905 3,285 2,857 2,736 3,107 3,104 3,086 36,231 ORA 2 0 10 1 0 0 1 0 1 0 0 0 15 OII 0 0 0 0 Totals 564,862 589,587 547,069 571,210 685,737 575,001 664,978 676,360 607,255 651,628 634,460 604,024 7,372,171
FDA ESG 2024 Monthly Acknowledgement Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 177,351 185,763 173,140 178,600 184,799 160,796 199,105 176,653 172,791 210,376 171,817 175,288 2,166,479 CDER 47,996 50,062 52,254 52,504 55,052 49,158 54,864 52,296 52,156 54,376 49,760 50,388 620,866 CBER 36,198 26,962 24,218 21,944 43,294 16,292 20,368 20,106 17,648 23,970 20,770 18,150 289,920 CDRH 972,825 1,045,629 953,532 1,008,249 1,291,089 1,089,798 1,225,482 1,337,175 1,144,383 1,138,863 1,223,154 1,115,814 13,545,993 CVM 23,492 20,678 21,558 23,358 24,902 22,346 23,254 20,580 22,744 23,014 19,722 19,892 265,540 OC 11,888 6,198 6,866 7,766 9,338 7,166 8,574 8,254 6,984 13,184 10,926 16,610 113,754 CTP 382 306 644 826 454 548 600 566 434 418 430 618 6,226 ACA 6 74 284 38 22 8 2 0 0 2 0 4 440 GDUFA 8 6 14 60 1,040 120 32 32 26 88 20 16 1,462 CFSAN 270 224 219 197 284 215 246 208 270 2,133 HFP 998 1,007 873 2,878 HC 5,958 5,828 5,874 6,162 6,480 5,810 6,570 5,714 5,472 6,214 6,208 6,172 72,462 ORA 2 0 10 1 0 0 1 0 1 15 OII 0 0 0 0 Totals 1,276,376 1,341,730 1,238,613 1,299,705 1,616,754 1,352,257 1,539,098 1,621,584 1,422,909 1,471,503 1,503,814 1,403,825 17,088,168
FDA ESG 2024 Monthly Total Traffic Statistics Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals AERS 354,702 371,526 346,280 357,200 369,598 321,592 398,210 353,306 345,582 420,752 343,634 350,576 4,332,958 CDER 71,994 75,093 78,381 78,756 82,578 73,737 82,296 78,444 78,234 81,564 74,640 75,582 931,299 CBER 54,297 40,443 36,327 32,916 64,941 24,438 30,552 30,159 26,472 35,955 31,155 27,225 434,880 CDRH 1,297,100 1,394,172 1,271,376 1,344,332 1,721,452 1,453,064 1,633,976 1,782,900 1,525,844 1,518,484 1,630,872 1,487,752 18,061,324 CVM 35,238 31,017 32,337 35,037 37,353 33,519 34,881 30,870 34,116 34,521 29,583 29,838 398,310 OC 17,832 9,297 10,299 11,649 14,007 10,749 12,861 12,381 10,476 19,776 16,389 24,915 170,631 CTP 573 459 966 1,239 681 822 900 849 651 627 645 927 9,339 ACA 9 111 426 57 33 12 3 0 0 3 0 6 660 GDUFA 12 9 21 90 1,560 180 48 48 39 132 30 24 2,193 CFSAN 540 448 438 394 568 430 492 416 540 4,266 HFP 1,996 2,014 1,746 5,756 HC 8,937 8,742 8,811 9,243 9,720 8,715 9,855 8,571 8,208 9,321 9,312 9,258 108,693 ORA 4 0 20 2 0 0 2 0 2 30 OII 0 0 0 0 Totals 1,841,238 1,931,317 1,785,682 1,870,915 2,302,491 1,927,258 2,204,076 2,297,944 2,030,164 2,123,131 2,138,274 2,007,849 24,460,339
Content current as of:
01/08/2026
