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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
378,774
19,450,474
CDER
139,322
159,515
165,932
189,141
221,471
236,584
259,284
283,135
286,917
298,049
51,552
2,290,902
CBER
9,506
11,294
20,278
52,197
56,044
70,900
74,545
716,525
646,370
194,261
32,823
1,884,743
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
704,452
27,669,043
CVM
44,607
52,601
64,197
70,436
70,682
74,750
86,437
88,216
85,983
106,500
22,692
767,101
OC
68,171
60,943
56,517
71,545
77,353
76,549
73,369
58,843
61,314
56,060
9,326
669,990
CTP
324
734
612
23,984
19,142
3,698
10,563
5,096
4,638
1,763
351
70,905
ACA
195
212
228
218
236
271
288
233
295
322
43
2,541
GDUFA
3,547
2,906
1,644
1,600
1,455
1,305
1,249
839
966
1,134
8
16,653
CFSAN
2,756
3,761
3,619
2,661
2,421
2,261
2,160
2,540
2,240
2,673
513
27,605
HC
5,835
9,366
16,497
23,595
26,927
27,302
35,167
40,392
37,634
38,039
6,171
266,925
ORA
57
58
27
2
144
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
1,206,707
53,117,026
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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
378,774
CDER
25,264
26,288
51,552
CBER
18,741
14,082
32,823
CDRH
340,896
363,556
704,452
CVM
12,085
10,607
22,692
OC
6,117
3,209
9,326
CTP
194
157
351
ACA
5
38
43
GDUFA
4
4
8
CFSAN
275
238
513
HC
3,111
3,060
6,171
ORA
2
0
2
Totals
592,092
614,615
1,206,707
FDA ESG 2024 Monthly Acknowledgement Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
185,398
193,376
378,774
CDER
50,528
52,576
103,104
CBER
37,482
28,164
65,646
CDRH
1,022,688
1,090,668
2,113,356
CVM
24,170
21,214
45,384
OC
12,234
6,418
18,652
CTP
388
314
702
ACA
10
76
86
GDUFA
8
8
16
CFSAN
275
238
513
HC
6,222
6,120
12,342
ORA
2
0
2
Totals
1,339,405
1,399,172
2,738,577
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
757,548
CDER
75,792
78,864
154,656
CBER
56,223
42,246
98,469
CDRH
1,363,584
1,454,224
2,817,808
CVM
36,255
31,821
68,076
OC
18,351
9,627
27,978
CTP
582
471
1,053
ACA
15
114
129
GDUFA
12
12
24
CFSAN
550
476
1,026
HC
9,333
9,180
18,513
ORA
4
0
4
Totals
1,931,497
2,013,787
3,945,284
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:
03/07/2024