FDA ESG 2014-2024 Total 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 2,042,295 21,113,995 CDER 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 286,917 298,049 294,327 2,533,677 CBER 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 646,370 194,261 139,109 1,991,029 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 4,259,883 31,224,474 CVM 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 85,983 106,500 125,643 870,052 OC 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 61,314 56,060 49,960 710,624 CTP 324 734 612 23,984 19,142 3,698 10,563 5,096 4,638 1,763 2,862 73,416 ACA 195 212 228 218 236 271 288 233 295 322 259 2,757 GDUFA 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 966 1,134 997 17,642 CFSAN 2,756 3,761 3,619 2,661 2,421 2,261 2,160 2,540 2,240 2,673 4,232 31,324 HFP 3 3 HC 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 37,634 38,039 33,988 294,742 ORA 57 58 27 14 156 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 6,953,572 58,863,891
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FDA ESG 2024 Monthly Submission Statistics 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 2,042,295 CDER 25,264 26,288 26,134 27,123 27,598 25,622 28,325 26,172 27,271 28,620 25,910 294,327 CBER 18,741 14,082 12,109 11,312 21,659 8,551 10,595 10,089 9,247 12,304 10,420 139,109 CDRH 340,896 363,556 317,844 348,358 432,142 381,393 426,715 447,484 396,950 394,566 409,979 4,259,883 CVM 12,085 10,607 10,779 11,937 12,466 11,533 11,903 10,430 12,407 11,608 9,888 125,643 OC 6,117 3,209 3,433 4,092 4,674 3,790 4,439 4,128 3,765 6,810 5,503 49,960 CTP 194 157 322 423 227 281 318 282 225 217 216 2,862 ACA 5 38 142 19 11 4 5 33 1 1 0 259 GDUFA 4 4 4 50 524 60 263 16 17 45 10 997 CFSAN 275 238 219 204 285 236 258 207 262 1,019 1,029 4,232 HFP 0 1 2 3 HC 3,111 3,060 2,937 3,187 3,246 2,938 3,437 2,856 2,871 3,237 3,108 33,988 ORA 2 0 10 1 0 0 1 0 0 0 0 14 Totals 592,092 614,615 547,069 590,638 688,852 603,040 693,271 678,919 634,416 672,537 638,123 6,953,572
FDA ESG 2024 Monthly Acknowledgement Statistics 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 2,042,295 CDER 50,528 52,576 52,268 54,246 55,196 51,244 56,650 52,344 54,542 57,240 51,820 588,654 CBER 37,482 28,164 24,218 22,624 43,318 17,102 21,190 20,178 18,494 24,608 20,840 278,218 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 12,779,649 CVM 24,170 21,214 21,558 23,874 24,932 23,066 23,806 20,860 24,814 23,216 19,776 251,286 OC 12,234 6,418 6,866 8,184 9,348 7,580 8,878 8,256 7,530 13,620 11,006 99,920 CTP 388 314 644 846 454 562 636 564 450 434 432 5,724 ACA 10 76 284 38 22 8 10 66 2 2 0 518 GDUFA 8 8 8 100 1,048 120 526 32 34 90 20 1,994 CFSAN 275 238 219 204 285 236 258 207 262 1,019 1,029 4,232 HFP 0 1 2 3 HC 6,222 6,120 5,874 6,374 6,492 5,876 6,874 5,712 5,742 6,474 6,216 67,976 ORA 2 0 10 1 0 0 1 0 0 0 0 14 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 16,120,483
FDA ESG 2024 Monthly Total Traffic Statistics 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 4,084,590 CDER 75,792 78,864 78,402 81,369 82,794 76,866 84,975 78,516 81,813 85,860 77,730 882,981 CBER 56,223 42,246 36,327 33,936 64,977 25,653 31,785 30,267 27,741 36,912 31,260 417,327 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 17,039,532 CVM 36,255 31,821 32,337 35,811 37,398 34,599 35,709 31,290 37,221 34,824 29,664 376,929 OC 18,351 9,627 10,299 12,276 14,022 11,370 13,317 12,384 11,295 20,430 16,509 149,880 CTP 582 471 966 1,269 681 843 954 846 675 651 648 8,586 ACA 15 114 426 57 33 12 15 99 3 3 0 777 GDUFA 12 12 12 150 1,572 180 789 48 51 135 30 2,991 CFSAN 550 476 438 408 570 472 516 414 524 2,038 2,058 8,464 HFP 0 2 4 6 HC 9,333 9,180 8,811 9,561 9,738 8,814 10,311 8,568 8,613 9,711 9,324 101,964 ORA 4 0 20 2 0 0 2 0 0 0 0 28 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 23,074,055
FDA ESG 2023 Monthly Submission Statistics 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
FDA ESG 2023 Monthly Acknowledgement Statistics 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
FDA ESG 2023 Monthly Total Traffic Statistics 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
Content current as of:
12/12/2024
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