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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
2,160,138
18,123,638
CDER
107,681
124,232
139,322
159,515
165,932
189,141
221,471
236,584
259,284
283,135
262,838
2,149,135
CBER
6,927
8,412
9,506
11,294
20,278
52,197
56,044
70,900
74,545
716,525
623,618
1,650,246
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
4,493,710
23,625,862
CVM
37,928
40,978
44,607
52,601
64,197
70,436
70,682
74,750
86,437
88,216
79,251
710,083
OC
64,285
65,430
68,171
60,943
56,517
71,545
77,353
76,549
73,369
58,843
52,592
725,597
CTP
642
1,237
324
734
612
23,984
19,142
3,698
10,563
5,096
4,416
70,448
ACA
62
207
195
212
228
218
236
271
288
233
294
2,444
GDUFA
2,771
2,926
3,547
2,906
1,644
1,600
1,455
1,305
1,249
839
938
21,180
CFSAN
458
4,220
2,756
3,761
3,619
2,661
2,421
2,261
2,160
2,540
2,053
28,910
HC
324
5,835
9,366
16,497
23,595
26,927
27,302
35,167
40,392
34,645
220,050
ORA
57
49
106
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
7,714,542
47,327,699
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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
200,937
206,910
207,807
2,160,138
CDER
21,590
24,083
26,823
23,048
24,172
24,461
22,173
24,453
25,146
22,797
24,092
262,838
CBER
73,087
75,334
68,794
56,245
53,078
57,907
61,450
55,999
62,999
30,590
28,135
623,618
CDRH
390,175
324,906
483,936
455,025
605,425
545,287
381,067
354,037
315,585
305,232
333,035
4,493,710
CVM
5,693
5,721
7,448
6,824
7,829
7,676
7,186
9,273
7,128
7,100
7,373
79,251
OC
7,106
5,766
4,372
4,780
3,889
3,867
3,070
3,406
3,486
5,655
7,195
52,592
CTP
177
267
349
207
1,615
273
376
279
312
209
352
4,416
ACA
3
16
240
20
8
0
2
0
2
2
1
294
GDUFA
15
11
48
22
669
71
17
18
24
24
19
938
CFSAN
156
170
218
167
246
195
204
237
152
178
130
2,053
HC
3,010
3,015
3,614
3,052
3,123
3,312
3,171
3,138
3,040
2,909
3,261
34,645
ORA
0
1
2
2
2
2
0
22
0
8
10
49
Totals
695,559
623,132
798,381
726,603
889,014
849,554
672,423
648,041
618,811
581,614
611,410
7,714,542
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
2,160,138
CDER
43,180
48,166
53,646
46,096
48,344
48,922
44,346
48,906
50,292
45,594
48,184
525,676
CBER
146,174
150,668
137,588
112,490
106,156
115,814
122,900
111,998
125,998
61,180
56,270
1,247,236
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
13,481,130
CVM
11,386
11,442
14,896
13,648
15,658
15,352
14,372
18,546
14,256
14,200
14,746
158,502
OC
14,212
11,532
8,744
9,560
7,778
7,734
6,140
6,812
6,972
11,310
14,390
105,184
CTP
354
534
698
414
3,230
546
752
558
624
418
704
8,832
ACA
6
32
480
40
16
0
4
0
4
4
2
588
GDUFA
30
22
96
44
1,338
142
34
36
48
48
38
1,876
CFSAN
156
170
218
167
246
195
204
237
152
178
130
2,053
HC
6,020
6,030
7,228
6,104
6,246
6,624
6,342
6,276
6,080
5,818
6,522
69,290
ORA
0
1
2
2
2
2
0
22
0
8
10
49
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
17,760,554
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
4,320,276
CDER
64,770
72,249
80,469
69,144
72,516
73,383
66,519
73,359
75,438
68,391
72,276
788,514
CBER
219,261
226,002
206,382
168,735
159,234
173,721
184,350
167,997
188,997
91,770
84,405
1,870,854
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
17,974,840
CVM
17,079
17,163
22,344
20,472
23,487
23,028
21,558
27,819
21,384
21,300
22,119
237,753
OC
21,318
17,298
13,116
14,340
11,667
11,601
9,210
10,218
10,458
16,965
21,585
157,776
CTP
531
801
1,047
621
4,845
819
1,128
837
936
627
1,056
13,248
ACA
9
48
720
60
24
0
6
0
6
6
3
882
GDUFA
45
33
144
66
2,007
213
51
54
72
72
57
2,814
CFSAN
312
340
436
334
492
390
408
474
304
356
260
4,106
HC
9,030
9,045
10,842
9,156
9,369
9,936
9,513
9,414
9,120
8,727
9,783
103,935
ORA
0
2
4
4
4
4
0
44
0
16
20
98
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
25,475,096
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
6,514
6,616
6,688
6,426
80,784
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
1,227,029
1,359,866
1,350,224
1,486,003
16,000,760
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
9,771
9,924
10,032
9,639
121,176
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
1,801,847
1,962,625
1,953,652
2,154,732
23,258,791
Content current as of:
12/13/2022