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FDA ESG 2012-2022 Total Submission Statistics
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Totals
AERS
717,345
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
1,347,305
17,310,805
CDER
107,681
124,232
139,322
159,515
165,932
189,141
221,471
236,584
259,284
283,135
166,350
2,052,647
CBER
6,927
8,412
9,506
11,294
20,278
52,197
56,044
70,900
74,545
716,525
445,895
1,472,523
CDRH
462,316
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
3,185,821
22,317,973
CVM
37,928
40,978
44,607
52,601
64,197
70,436
70,682
74,750
86,437
88,216
48,377
679,209
OC
64,285
65,430
68,171
60,943
56,517
71,545
77,353
76,549
73,369
58,843
32,850
705,855
CTP
642
1,237
324
734
612
23,984
19,142
3,698
10,563
5,096
3,264
69,296
ACA
62
207
195
212
228
218
236
271
288
233
289
2,439
GDUFA
2,771
2,926
3,547
2,906
1,644
1,600
1,455
1,305
1,249
839
853
21,095
CFSAN
458
4,220
2,756
3,761
3,619
2,661
2,421
2,261
2,160
2,540
1,356
28,213
HC
324
5,835
9,366
16,497
23,595
26,927
27,302
35,167
40,392
22,297
207,702
ORA
57
9
66
Totals
1,400,415
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
5,254,666
44,867,823
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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
1,347,305
CDER
21,590
24,083
26,823
23,048
24,172
24,461
22,173
166,350
CBER
73,087
75,334
68,794
56,245
53,078
57,907
61,450
445,895
CDRH
390,175
324,906
483,936
455,025
605,425
545,287
381,067
3,185,821
CVM
5,693
5,721
7,448
6,824
7,829
7,676
7,186
48,377
OC
7,106
5,766
4,372
4,780
3,889
3,867
3,070
32,850
CTP
177
267
349
207
1,615
273
376
3,264
ACA
3
16
240
20
8
0
2
289
GDUFA
15
11
48
22
669
71
17
853
CFSAN
156
170
218
167
246
195
204
1,356
HC
3,010
3,015
3,614
3,052
3,123
3,312
3,171
22,297
ORA
0
1
2
2
2
2
0
9
Totals
695,559
623,132
798,381
726,603
889,014
849,554
672,423
5,254,666
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
1,347,305
CDER
43,180
48,166
53,646
46,096
48,344
48,922
44,346
332,700
CBER
146,174
150,668
137,588
112,490
106,156
115,814
122,900
891,790
CDRH
1,170,525
974,718
1,451,808
1,365,075
1,816,275
1,635,861
1,143,201
9,557,463
CVM
11,386
11,442
14,896
13,648
15,658
15,352
14,372
96,754
OC
14,212
11,532
8,744
9,560
7,778
7,734
6,140
65,700
CTP
354
534
698
414
3,230
546
752
6,528
ACA
6
32
480
40
16
0
4
578
GDUFA
30
22
96
44
1,338
142
34
1,706
CFSAN
156
170
218
167
246
195
204
1,356
HC
6,020
6,030
7,228
6,104
6,246
6,624
6,342
44,594
ORA
0
1
2
2
2
2
0
9
Totals
1,586,590
1,387,157
1,877,941
1,730,851
2,194,247
2,037,695
1,532,002
12,346,483
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
2,694,610
CDER
64,770
72,249
80,469
69,144
72,516
73,383
66,519
499,050
CBER
219,261
226,002
206,382
168,735
159,234
173,721
184,350
1,337,685
CDRH
1,560,700
1,299,624
1,935,744
1,820,100
2,421,700
2,181,148
1,524,268
12,743,284
CVM
17,079
17,163
22,344
20,472
23,487
23,028
21,558
145,131
OC
21,318
17,298
13,116
14,340
11,667
11,601
9,210
98,550
CTP
531
801
1,047
621
4,845
819
1,128
9,792
ACA
9
48
720
60
24
0
6
867
GDUFA
45
33
144
66
2,007
213
51
2,559
CFSAN
312
340
436
334
492
390
408
2,712
HC
9,030
9,045
10,842
9,156
9,369
9,936
9,513
66,891
ORA
0
2
4
4
4
4
0
18
Totals
2,282,149
2,010,289
2,676,322
2,457,454
3,083,261
2,887,249
2,204,425
17,601,149
FDA ESG 2021 Monthly Submission Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
182,833
185,634
198,270
183,702
200,409
184,877
219,943
193,590
191,144
169,348
175,952
201,728
2,287,430
CDER
19,068
20,894
24,711
23,577
23,440
24,812
23,754
23,795
24,783
25,164
24,230
24,907
283,135
CBER
18,930
26,675
31,183
46,014
46,600
56,094
71,441
137,355
75,191
66,984
65,970
74,088
716,525
CDRH
323,386
252,371
332,767
288,054
269,252
324,867
339,939
381,403
268,729
323,952
319,559
350,446
3,774,725
CVM
5,910
5,890
7,728
6,752
7,498
8,592
7,783
8,526
7,330
7,676
7,988
6,543
88,216
OC
5,649
4,004
5,004
4,988
3,856
4,794
4,389
3,802
3,529
5,792
5,870
7,166
58,843
CTP
420
498
523
334
375
691
484
432
644
252
246
197
5,096
ACA
6
23
158
19
5
1
1
7
1
2
5
5
233
GDUFA
19
21
25
32
263
92
33
23
18
25
25
263
839
CFSAN
175
190
211
248
196
254
213
215
191
247
231
169
2,540
HC
3,157
3,259
3,869
3,236
3,231
3,619
3,589
3,310
3,257
3,308
3,344
3,213
40,392
ORA
3
5
3
15
9
1
9
8
4
57
Totals
559,553
499,459
604,449
556,959
555,130
608,696
671,584
752,467
574,818
602,759
603,428
668,729
7,258,031
FDA ESG 2021 Monthly Acknowledgement Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
182,833
185,634
198,270
183,702
200,409
184,877
219,943
193,590
191,144
169,348
175,952
201,728
2,287,430
CDER
38,136
41,788
49,422
47,154
46,880
49,624
47,508
47,590
49,566
50,328
48,460
49,814
566,270
CBER
37,860
53,350
62,366
92,028
93,200
112,188
142,882
274,710
150,382
133,968
131,940
148,176
1,433,050
CDRH
970,158
757,113
998,301
864,162
807,756
974,601
1,019,817
1,144,209
806,187
971,856
958,677
1,051,338
11,324,175
CVM
11,820
11,780
15,456
13,504
14,996
17,184
15,566
17,052
14,660
15,352
15,976
13,086
176,432
OC
11,298
8,008
10,008
9,976
7,712
9,588
8,778
7,604
7,058
11,584
11,740
14,332
117,686
CTP
840
996
1,046
668
750
1,382
968
864
1,288
504
492
394
10,192
ACA
12
46
316
38
10
2
2
14
2
4
10
10
466
GDUFA
38
42
50
64
526
184
66
46
36
50
50
526
1,678
CFSAN
175
190
211
248
196
254
213
215
191
247
231
169
2,540
HC
6,314
6,518
7,738
6,472
6,462
7,238
7,178
6,620
382
494
462
338
56,216
ORA
3
5
3
15
9
1
9
8
4
57
Totals
1,259,484
1,065,465
1,339,526
1,218,019
1,178,902
1,357,125
1,462,936
1,692,523
1,220,897
1,353,744
1,343,998
1,479,915
15,972,534
FDA ESG 2021 Monthly Total Traffic Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
365,666
371,268
396,540
367,404
400,818
369,754
439,886
387,180
382,288
338,696
351,904
403,456
4,574,860
CDER
57,204
62,682
74,133
70,731
70,320
74,436
71,262
71,385
74,349
75,492
72,690
74,721
849,405
CBER
56,790
80,025
93,549
138,042
139,800
168,282
214,323
412,065
225,573
200,952
197,910
222,264
2,149,575
CDRH
1,293,544
1,009,484
1,331,068
1,152,216
1,077,008
1,299,468
1,359,756
1,525,612
1,074,916
1,295,808
1,278,236
1,401,784
15,098,900
CVM
17,730
17,670
23,184
20,256
22,494
25,776
23,349
25,578
21,990
23,028
23,964
19,629
264,648
OC
16,947
12,012
15,012
14,964
11,568
14,382
13,167
11,406
10,587
17,376
17,610
21,498
176,529
CTP
1,260
1,494
1,569
1,002
1,125
2,073
1,452
1,296
1,932
756
738
591
15,288
ACA
18
69
474
57
15
3
3
21
3
6
15
15
699
GDUFA
57
63
75
96
789
276
99
69
54
75
75
789
2,517
CFSAN
350
380
422
496
392
508
426
430
382
494
462
338
5,080
HC
9,471
9,777
11,607
9,708
9,693
10,857
10,767
9,930
573
741
693
507
84,324
ORA
6
10
6
30
18
2
18
16
8
114
Totals
1,819,037
1,564,924
1,943,975
1,774,978
1,734,032
1,965,821
2,134,520
2,444,990
1,792,649
1,953,442
1,944,313
2,145,600
23,218,281
Content current as of:
08/12/2022