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FDA ESG 2013-2023 Total Submission Statistics
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Totals
AERS
876,475
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
971,463
18,590,032
CDER
124,232
139,322
159,515
165,932
189,141
221,471
236,584
259,284
283,135
286,917
119,306
2,184,839
CBER
8,412
9,506
11,294
20,278
52,197
56,044
70,900
74,545
716,525
646,370
95,739
1,761,810
CDRH
666,927
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
1,688,586
25,210,060
CVM
40,978
44,607
52,601
64,197
70,436
70,682
74,750
86,437
88,216
85,983
39,646
718,533
OC
65,430
68,171
60,943
56,517
71,545
77,353
76,549
73,369
58,843
61,314
20,847
690,881
CTP
1,237
324
734
612
23,984
19,142
3,698
10,563
5,096
4,638
721
70,749
ACA
207
195
212
228
218
236
271
288
233
295
303
2,686
GDUFA
2,926
3,547
2,906
1,644
1,600
1,455
1,305
1,249
839
966
632
19,069
CFSAN
4,220
2,756
3,761
3,619
2,661
2,421
2,261
2,160
2,540
2,240
1,060
29,699
HC
324
5,835
9,366
16,497
23,595
26,927
27,302
35,167
40,392
37,634
15,596
238,635
ORA
57
58
14
129
Totals
1,791,368
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
2,953,913
49,517,122
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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
971,463
CDER
21,089
22,110
27,118
23,105
25,884
119,306
CBER
20,825
17,530
25,459
15,241
16,684
95,739
CDRH
318,486
308,034
376,811
365,283
319,972
1,688,586
CVM
8,401
6,596
8,161
7,699
8,789
39,646
OC
5,830
4,472
4,279
3,012
3,254
20,847
CTP
118
194
182
105
122
721
ACA
3
25
247
28
0
303
GDUFA
11
19
35
11
556
632
CFSAN
137
173
336
180
234
1,060
HC
2,853
2,977
3,480
2,844
3,442
15,596
ORA
1
7
5
1
0
14
Totals
579,133
550,365
648,639
598,577
577,199
2,953,913
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
971,463
CDER
42,178
44,220
54,236
46,210
51,768
238,612
CBER
41,650
35,060
50,918
30,482
33,368
191,478
CDRH
955,458
924,102
1,130,433
1,095,849
959,916
5,065,758
CVM
16,802
13,192
16,322
15,398
17,578
79,292
OC
11,660
8,944
8,558
6,024
6,508
41,694
CTP
236
388
364
210
244
1,442
ACA
6
50
494
56
0
606
GDUFA
22
38
70
22
1,112
1,264
CFSAN
137
173
336
180
234
1,060
HC
5,706
5,954
6,960
5,688
6,884
31,192
ORA
1
7
5
1
0
14
Totals
1,275,235
1,220,356
1,471,222
1,381,188
1,275,874
6,623,875
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
1,942,926
CDER
63,267
66,330
81,354
69,315
77,652
357,918
CBER
62,475
52,590
76,377
45,723
50,052
287,217
CDRH
1,273,944
1,232,136
1,507,244
1,461,132
1,279,888
6,754,344
CVM
25,203
19,788
24,483
23,097
26,367
118,938
OC
17,490
13,416
12,837
9,036
9,762
62,541
CTP
354
582
546
315
366
2,163
ACA
9
75
741
84
0
909
GDUFA
33
57
105
33
1,668
1,896
CFSAN
274
346
672
360
468
2,120
HC
8,559
8,931
10,440
8,532
10,326
46,788
ORA
2
14
10
2
0
28
Totals
1,854,368
1,770,721
2,119,861
1,979,765
1,853,073
9,577,788
FDA ESG 2022 Monthly Submission Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
194,547
183,842
202,537
177,211
188,958
206,503
193,707
197,179
200,937
206,910
207,807
212,276
2,372,414
CDER
21,590
24,083
26,823
23,048
24,172
24,461
22,173
24,453
25,146
22,797
24,092
24,079
286,917
CBER
73,087
75,334
68,794
56,245
53,078
57,907
61,450
55,999
62,999
30,590
28,135
22,752
646,370
CDRH
390,175
324,906
483,936
455,025
605,425
545,287
381,067
354,037
315,585
305,232
333,035
357,928
4,851,638
CVM
5,693
5,721
7,448
6,824
7,829
7,676
7,186
9,273
7,128
7,100
7,373
6,732
85,983
OC
7,106
5,766
4,372
4,780
3,889
3,867
3,070
3,406
3,486
5,655
7,195
8,722
61,314
CTP
177
267
349
207
1,615
273
376
279
312
209
352
222
4,638
ACA
3
16
240
20
8
0
2
0
2
2
1
1
295
GDUFA
15
11
48
22
669
71
17
18
24
24
19
28
966
CFSAN
156
170
218
167
246
195
204
237
152
178
130
187
2,240
HC
3,010
3,015
3,614
3,052
3,123
3,312
3,171
3,138
3,040
2,909
3,261
2,989
37,634
ORA
0
1
2
2
2
2
0
22
0
8
10
9
58
Totals
695,559
623,132
798,381
726,603
889,014
849,554
672,423
648,041
618,811
581,614
611,410
635,925
8,350,467
FDA ESG 2022 Monthly Acknowledgement Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
194,547
183,842
202,537
177,211
188,958
206,503
193,707
197,179
200,937
206,910
207,807
212,276
2,372,414
CDER
43,180
48,166
53,646
46,096
48,344
48,922
44,346
48,906
50,292
45,594
48,184
48,158
573,834
CBER
146,174
150,668
137,588
112,490
106,156
115,814
122,900
111,998
125,998
61,180
56,270
45,504
1,292,740
CDRH
1,170,525
974,718
1,451,808
1,365,075
1,816,275
1,635,861
1,143,201
1,062,111
946,755
915,696
999,105
1,073,784
14,554,914
CVM
11,386
11,442
14,896
13,648
15,658
15,352
14,372
18,546
14,256
14,200
14,746
13,464
171,966
OC
14,212
11,532
8,744
9,560
7,778
7,734
6,140
6,812
6,972
11,310
14,390
17,444
122,628
CTP
354
534
698
414
3,230
546
752
558
624
418
704
444
9,276
ACA
6
32
480
40
16
0
4
0
4
4
2
2
590
GDUFA
30
22
96
44
1,338
142
34
36
48
48
38
56
1,932
CFSAN
156
170
218
167
246
195
204
237
152
178
130
187
2,240
HC
6,020
6,030
7,228
6,104
6,246
6,624
6,342
6,276
6,080
5,818
6,522
5,978
75,268
ORA
0
1
2
2
2
2
0
22
0
8
10
9
58
Totals
1,586,590
1,387,157
1,877,941
1,730,851
2,194,247
2,037,695
1,532,002
1,452,681
1,352,118
1,261,364
1,347,908
1,417,306
19,177,860
FDA ESG 2022 Monthly Total Traffic Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
389,094
367,684
405,074
354,422
377,916
413,006
387,414
394,358
401,874
413,820
415,614
424,552
4,744,828
CDER
64,770
72,249
80,469
69,144
72,516
73,383
66,519
73,359
75,438
68,391
72,276
72,237
860,751
CBER
219,261
226,002
206,382
168,735
159,234
173,721
184,350
167,997
188,997
91,770
84,405
68,256
1,939,110
CDRH
1,560,700
1,299,624
1,935,744
1,820,100
2,421,700
2,181,148
1,524,268
1,416,148
1,262,340
1,220,928
1,332,140
1,431,712
19,406,552
CVM
17,079
17,163
22,344
20,472
23,487
23,028
21,558
27,819
21,384
21,300
22,119
20,196
257,949
OC
21,318
17,298
13,116
14,340
11,667
11,601
9,210
10,218
10,458
16,965
21,585
26,166
183,942
CTP
531
801
1,047
621
4,845
819
1,128
837
936
627
1,056
666
13,914
ACA
9
48
720
60
24
0
6
0
6
6
3
3
885
GDUFA
45
33
144
66
2,007
213
51
54
72
72
57
84
2,898
CFSAN
312
340
436
334
492
390
408
474
304
356
260
374
4,480
HC
9,030
9,045
10,842
9,156
9,369
9,936
9,513
9,414
9,120
8,727
9,783
8,967
112,902
ORA
0
2
4
4
4
4
0
44
0
16
20
18
116
Totals
2,282,149
2,010,289
2,676,322
2,457,454
3,083,261
2,887,249
2,204,425
2,100,722
1,970,929
1,842,978
1,959,318
2,053,231
27,528,327
Content current as of:
06/01/2023