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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
1,544,484
17,507,984
CDER
107,681
124,232
139,322
159,515
165,932
189,141
221,471
236,584
259,284
283,135
190,803
2,077,100
CBER
6,927
8,412
9,506
11,294
20,278
52,197
56,044
70,900
74,545
716,525
501,894
1,528,522
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
3,539,858
22,672,010
CVM
37,928
40,978
44,607
52,601
64,197
70,436
70,682
74,750
86,437
88,216
57,650
688,482
OC
64,285
65,430
68,171
60,943
56,517
71,545
77,353
76,549
73,369
58,843
36,256
709,261
CTP
642
1,237
324
734
612
23,984
19,142
3,698
10,563
5,096
3,543
69,575
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
871
21,113
CFSAN
458
4,220
2,756
3,761
3,619
2,661
2,421
2,261
2,160
2,540
1,593
28,450
HC
324
5,835
9,366
16,497
23,595
26,927
27,302
35,167
40,392
25,435
210,840
ORA
57
31
88
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
5,902,707
45,515,864
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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
197,179
1,544,484
CDER
21,590
24,083
26,823
23,048
24,172
24,461
22,173
24,453
190,803
CBER
73,087
75,334
68,794
56,245
53,078
57,907
61,450
55,999
501,894
CDRH
390,175
324,906
483,936
455,025
605,425
545,287
381,067
354,037
3,539,858
CVM
5,693
5,721
7,448
6,824
7,829
7,676
7,186
9,273
57,650
OC
7,106
5,766
4,372
4,780
3,889
3,867
3,070
3,406
36,256
CTP
177
267
349
207
1,615
273
376
279
3,543
ACA
3
16
240
20
8
0
2
0
289
GDUFA
15
11
48
22
669
71
17
18
871
CFSAN
156
170
218
167
246
195
204
237
1,593
HC
3,010
3,015
3,614
3,052
3,123
3,312
3,171
3,138
25,435
ORA
0
1
2
2
2
2
0
22
31
Totals
695,559
623,132
798,381
726,603
889,014
849,554
672,423
648,041
5,902,707
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
1,544,484
CDER
43,180
48,166
53,646
46,096
48,344
48,922
44,346
48,906
381,606
CBER
146,174
150,668
137,588
112,490
106,156
115,814
122,900
111,998
1,003,788
CDRH
1,170,525
974,718
1,451,808
1,365,075
1,816,275
1,635,861
1,143,201
1,062,111
10,619,574
CVM
11,386
11,442
14,896
13,648
15,658
15,352
14,372
18,546
115,300
OC
14,212
11,532
8,744
9,560
7,778
7,734
6,140
6,812
72,512
CTP
354
534
698
414
3,230
546
752
558
7,086
ACA
6
32
480
40
16
0
4
0
578
GDUFA
30
22
96
44
1,338
142
34
36
1,742
CFSAN
156
170
218
167
246
195
204
237
1,593
HC
6,020
6,030
7,228
6,104
6,246
6,624
6,342
6,276
50,870
ORA
0
1
2
2
2
2
0
22
31
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
13,799,164
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
3,088,968
CDER
64,770
72,249
80,469
69,144
72,516
73,383
66,519
73,359
572,409
CBER
219,261
226,002
206,382
168,735
159,234
173,721
184,350
167,997
1,505,682
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
14,159,432
CVM
17,079
17,163
22,344
20,472
23,487
23,028
21,558
27,819
172,950
OC
21,318
17,298
13,116
14,340
11,667
11,601
9,210
10,218
108,768
CTP
531
801
1,047
621
4,845
819
1,128
837
10,629
ACA
9
48
720
60
24
0
6
0
867
GDUFA
45
33
144
66
2,007
213
51
54
2,613
CFSAN
312
340
436
334
492
390
408
474
3,186
HC
9,030
9,045
10,842
9,156
9,369
9,936
9,513
9,414
76,305
ORA
0
2
4
4
4
4
0
44
62
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
19,701,871
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:
09/12/2022