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 | 2,217,583 | 21,289,283 |
CDER | 139,322 | 159,515 | 165,932 | 189,141 | 221,471 | 236,584 | 259,284 | 283,135 | 286,917 | 298,049 | 319,521 | 2,558,871 |
CBER | 9,506 | 11,294 | 20,278 | 52,197 | 56,044 | 70,900 | 74,545 | 716,525 | 646,370 | 194,261 | 148,184 | 2,000,104 |
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 | 4,631,821 | 31,596,412 |
CVM | 44,607 | 52,601 | 64,197 | 70,436 | 70,682 | 74,750 | 86,437 | 88,216 | 85,983 | 106,500 | 135,589 | 879,998 |
OC | 68,171 | 60,943 | 56,517 | 71,545 | 77,353 | 76,549 | 73,369 | 58,843 | 61,314 | 56,060 | 58,265 | 718,929 |
CTP | 324 | 734 | 612 | 23,984 | 19,142 | 3,698 | 10,563 | 5,096 | 4,638 | 1,763 | 3,171 | 73,725 |
ACA | 195 | 212 | 228 | 218 | 236 | 271 | 288 | 233 | 295 | 322 | 261 | 2,759 |
GDUFA | 3,547 | 2,906 | 1,644 | 1,600 | 1,455 | 1,305 | 1,249 | 839 | 966 | 1,134 | 1,005 | 17,650 |
CFSAN * | 2,756 | 3,761 | 3,619 | 2,661 | 2,421 | 2,261 | 2,160 | 2,540 | 2,240 | 2,673 | 2,184 | 29,276 |
HFP * | 2,924 | 2,924 | ||||||||||
HC | 5,835 | 9,366 | 16,497 | 23,595 | 26,927 | 27,302 | 35,167 | 40,392 | 37,634 | 38,039 | 37,074 | 297,828 |
ORA * | 57 | 58 | 27 | 14 | 156 | |||||||
OII * | 0 | 0 | 0 | 0 | ||||||||
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 | 7,557,596 | 59,467,915 |
Note: * On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency.
Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sept | Oct | Nov | Dec | Totals | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AERS | 185,398 | 193,376 | 173,136 | 183,932 | 186,020 | 168,632 | 207,012 | 177,222 | 181,400 | 214,109 | 172,058 | 175,288 | 2,217,583 |
CDER | 25,264 | 26,288 | 26,134 | 27,123 | 27,598 | 25,622 | 28,325 | 26,172 | 27,271 | 28,620 | 25,910 | 25,194 | 319,521 |
CBER | 18,741 | 14,082 | 12,109 | 11,312 | 21,659 | 8,551 | 10,595 | 10,089 | 9,247 | 12,304 | 10,420 | 9,075 | 148,184 |
CDRH | 340,896 | 363,556 | 317,844 | 348,358 | 432,142 | 381,393 | 426,715 | 447,484 | 396,950 | 394,566 | 409,979 | 371,938 | 4,631,821 |
CVM | 12,085 | 10,607 | 10,779 | 11,937 | 12,466 | 11,533 | 11,903 | 10,430 | 12,407 | 11,608 | 9,888 | 9,946 | 135,589 |
OC | 6,117 | 3,209 | 3,433 | 4,092 | 4,674 | 3,790 | 4,439 | 4,128 | 3,765 | 6,810 | 5,503 | 8,305 | 58,265 |
CTP | 194 | 157 | 322 | 423 | 227 | 281 | 318 | 282 | 225 | 217 | 216 | 309 | 3,171 |
ACA | 5 | 38 | 142 | 19 | 11 | 4 | 5 | 33 | 1 | 1 | 0 | 2 | 261 |
GDUFA | 4 | 4 | 4 | 50 | 524 | 60 | 263 | 16 | 17 | 45 | 10 | 8 | 1,005 |
CFSAN | 275 | 238 | 219 | 204 | 285 | 236 | 258 | 207 | 262 | 2,184 | |||
HFP | 1,020 | 1,031 | 873 | 2,924 | |||||||||
HC | 3,111 | 3,060 | 2,937 | 3,187 | 3,246 | 2,938 | 3,437 | 2,856 | 2,871 | 3,237 | 3,108 | 3,086 | 37,074 |
ORA | 2 | 0 | 10 | 1 | 0 | 0 | 1 | 0 | 0 | 14 | |||
OII | 0 | 0 | 0 | 0 | |||||||||
Totals | 592,092 | 614,615 | 547,069 | 590,638 | 688,852 | 603,040 | 693,271 | 678,919 | 634,416 | 672,537 | 638,123 | 604,024 | 7,557,596 |
Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sept | Oct | Nov | Dec | Totals | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AERS | 185,398 | 193,376 | 173,136 | 183,932 | 186,020 | 168,632 | 207,012 | 177,222 | 181,400 | 214,109 | 172,058 | 175,288 | 2,217,583 |
CDER | 50,528 | 52,576 | 52,268 | 54,246 | 55,196 | 51,244 | 56,650 | 52,344 | 54,542 | 57,240 | 51,820 | 50,388 | 639,042 |
CBER | 37,482 | 28,164 | 24,218 | 22,624 | 43,318 | 17,102 | 21,190 | 20,178 | 18,494 | 24,608 | 20,840 | 18,150 | 296,368 |
CDRH | 1,022,688 | 1,090,668 | 953,532 | 1,045,074 | 1,296,426 | 1,144,179 | 1,280,145 | 1,342,452 | 1,190,850 | 1,183,698 | 1,229,937 | 1,115,814 | 13,895,463 |
CVM | 24,170 | 21,214 | 21,558 | 23,874 | 24,932 | 23,066 | 23,806 | 20,860 | 24,814 | 23,216 | 19,776 | 19,892 | 271,178 |
OC | 12,234 | 6,418 | 6,866 | 8,184 | 9,348 | 7,580 | 8,878 | 8,256 | 7,530 | 13,620 | 11,006 | 16,610 | 116,530 |
CTP | 388 | 314 | 644 | 846 | 454 | 562 | 636 | 564 | 450 | 434 | 432 | 618 | 6,342 |
ACA | 10 | 76 | 284 | 38 | 22 | 8 | 10 | 66 | 2 | 2 | 0 | 4 | 522 |
GDUFA | 8 | 8 | 8 | 100 | 1,048 | 120 | 526 | 32 | 34 | 90 | 20 | 16 | 2,010 |
CFSAN | 275 | 238 | 219 | 204 | 285 | 236 | 258 | 207 | 262 | 2,184 | |||
HFP | 1,020 | 1,031 | 873 | 2,924 | |||||||||
HC | 6,222 | 6,120 | 5,874 | 6,374 | 6,492 | 5,876 | 6,874 | 5,712 | 5,742 | 6,474 | 6,216 | 6,172 | 74,148 |
ORA | 2 | 0 | 10 | 1 | 0 | 0 | 1 | 0 | 0 | 14 | |||
OII | 0 | 0 | 0 | 0 | |||||||||
Totals | 1,339,405 | 1,399,172 | 1,238,617 | 1,345,497 | 1,623,541 | 1,418,605 | 1,605,986 | 1,627,893 | 1,484,120 | 1,524,511 | 1,513,136 | 1,403,825 | 17,524,308 |
Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sept | Oct | Nov | Dec | Totals | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AERS | 370,796 | 386,752 | 346,272 | 367,864 | 372,040 | 337,264 | 414,024 | 354,444 | 362,800 | 428,218 | 344,116 | 350,576 | 4,435,166 |
CDER | 75,792 | 78,864 | 78,402 | 81,369 | 82,794 | 76,866 | 84,975 | 78,516 | 81,813 | 85,860 | 77,730 | 75,582 | 958,563 |
CBER | 56,223 | 42,246 | 36,327 | 33,936 | 64,977 | 25,653 | 31,785 | 30,267 | 27,741 | 36,912 | 31,260 | 27,225 | 444,552 |
CDRH | 1,363,584 | 1,454,224 | 1,271,376 | 1,393,432 | 1,728,568 | 1,525,572 | 1,706,860 | 1,789,936 | 1,587,800 | 1,578,264 | 1,639,916 | 1,487,752 | 18,527,284 |
CVM | 36,255 | 31,821 | 32,337 | 35,811 | 37,398 | 34,599 | 35,709 | 31,290 | 37,221 | 34,824 | 29,664 | 29,838 | 406,767 |
OC | 18,351 | 9,627 | 10,299 | 12,276 | 14,022 | 11,370 | 13,317 | 12,384 | 11,295 | 20,430 | 16,509 | 24,915 | 174,795 |
CTP | 582 | 471 | 966 | 1,269 | 681 | 843 | 954 | 846 | 675 | 651 | 648 | 927 | 9,513 |
ACA | 15 | 114 | 426 | 57 | 33 | 12 | 15 | 99 | 3 | 3 | 0 | 6 | 783 |
GDUFA | 12 | 12 | 12 | 150 | 1,572 | 180 | 789 | 48 | 51 | 135 | 30 | 24 | 3,015 |
CFSAN | 550 | 476 | 438 | 408 | 570 | 472 | 516 | 414 | 524 | 4,368 | |||
HFP | 2,040 | 2,062 | 1,746 | 5,848 | |||||||||
HC | 9,333 | 9,180 | 8,811 | 9,561 | 9,738 | 8,814 | 10,311 | 8,568 | 8,613 | 9,711 | 9,324 | 9,258 | 111,222 |
ORA | 4 | 0 | 20 | 2 | 0 | 0 | 2 | 0 | 0 | 28 | |||
OII | 0 | 0 | 0 | 0 | |||||||||
Totals | 1,931,497 | 2,013,787 | 1,785,686 | 1,936,135 | 2,312,393 | 2,021,645 | 2,299,257 | 2,306,812 | 2,118,536 | 2,197,048 | 2,151,259 | 2,007,849 | 25,081,904 |
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 |
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 |
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 |