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FDA ESG 2011-2021 Total Submission Statistics
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
Totals
AERS
557,917
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
1,740,402
15,974,389
CDER
93,503
107,681
124,232
139,322
159,515
165,932
189,141
221,471
236,584
259,284
208,834
1,905,499
CBER
6397
6,927
8,412
9,506
11,294
20,278
52,197
56,044
70,900
74,545
509,483
825,983
CDRH
280,312
462,316
666,927
812,443
1,478,524
2,032,767
1,921,871
2,247,286
2,774,852
2,960,441
2,780,768
18,418,507
CVM
20,462
37,928
40,978
44,607
52,601
64,197
70,436
70,682
74,750
86,437
66,009
629,087
OC
55,676
64,285
65,430
68,171
60,943
56,517
71,545
77,353
76,549
73,369
40,015
709,853
CTP
348
642
1,237
324
734
612
23,984
19,142
3,698
10,563
4,401
65,685
ACA
62
207
195
212
228
218
236
271
288
221
2,138
GDUFA
2,771
2,926
3,547
2,906
1,644
1,600
1,455
1,305
1,249
526
19,929
CFSAN
458
4,220
2,756
3,761
3,619
2,661
2,421
2,261
2,160
5,551
29,868
HC
324
5,835
9,366
16,497
23,595
26,927
27,302
35,167
26,869
171,882
ORA
36
36
Totals
1,014,615
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
5,383,115
38,752,856
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
1,740,402
CDER
19,068
20,894
24,711
23,577
23,440
24,812
23,754
23,795
24,783
208,834
CBER
18,930
26,675
31,183
46,014
46,600
56,094
71,441
137,355
75,191
509,483
CDRH
323,386
252,371
332,767
288,054
269,252
324,867
339,939
381,403
268,729
2,780,768
CVM
5,910
5,890
7,728
6,752
7,498
8,592
7,783
8,526
7,330
66,009
OC
5,649
4,004
5,004
4,988
3,856
4,794
4,389
3,802
3,529
40,015
CTP
420
498
523
334
375
691
484
432
644
4,401
ACA
6
23
158
19
5
1
1
7
1
221
GDUFA
19
21
25
32
263
92
33
23
18
526
CFSAN
175
190
3,869
248
196
254
213
215
191
5,551
HC
3,157
3,259
211
3,236
3,231
3,619
3,589
3,310
3,257
26,869
ORA
3
5
3
15
9
1
36
Totals
559,553
499,459
604,449
556,959
555,130
608,696
671,584
752,467
574,818
5,383,115
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
1,740,402
CDER
38,136
41,788
49,422
47,154
46,880
49,624
47,508
47,590
49,566
417,668
CBER
37,860
53,350
62,366
92,028
93,200
112,188
142,882
274,710
150,382
1,018,966
CDRH
970,158
757,113
998,301
864,162
807,756
974,601
1,019,817
1,144,209
806,187
8,342,304
CVM
11,820
11,780
15,456
13,504
14,996
17,184
15,566
17,052
14,660
132,018
OC
11,298
8,008
10,008
9,976
7,712
9,588
8,778
7,604
7,058
80,030
CTP
840
996
1,046
668
750
1,382
968
864
1,288
8,802
ACA
12
46
316
38
10
2
2
14
2
442
GDUFA
38
42
50
64
526
184
66
46
36
1,052
CFSAN
175
190
3,869
248
196
254
213
215
191
5,551
HC
6,314
6,518
422
6,472
6,462
7,238
7,178
6,620
382
47,606
ORA
3
5
3
15
9
1
36
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
11,794,877
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
3,480,804
CDER
57,204
62,682
74,133
70,731
70,320
74,436
71,262
71,385
74,349
626,502
CBER
56,790
80,025
93,549
138,042
139,800
168,282
214,323
412,065
225,573
1,528,449
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
11,123,072
CVM
17,730
17,670
23,184
20,256
22,494
25,776
23,349
25,578
21,990
198,027
OC
16,947
12,012
15,012
14,964
11,568
14,382
13,167
11,406
10,587
120,045
CTP
1,260
1,494
1,569
1,002
1,125
2,073
1,452
1,296
1,932
13,203
ACA
18
69
474
57
15
3
3
21
3
663
GDUFA
57
63
75
96
789
276
99
69
54
1,578
CFSAN
350
380
7,738
496
392
508
426
430
382
11,102
HC
9,471
9,777
633
9,708
9,693
10,857
10,767
9,930
573
71,409
ORA
6
10
6
30
18
2
72
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
17,174,926
FDA ESG 2020 Monthly Submission Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
204,918
180,498
186,259
184,920
173,310
182,363
194,758
172,313
182,097
185,758
180,080
197,229
2,224,503
CDER
19,770
19,397
21,774
22,023
20,616
22,158
22,676
20,603
22,397
23,368
21,141
23,361
259,284
CBER
6,325
5,477
6,888
6,422
4,985
5,001
6,066
5,486
5,720
6,506
6,590
9,079
74,545
CDRH
261,384
233,864
250,764
225,618
192,993
236,836
250,483
216,666
253,108
265,993
279,854
292,878
2,960,441
CVM
6,447
6,087
7,019
6,032
6,725
8,817
8,529
7,235
7,971
7,768
6,772
7,035
86,437
OC
8,511
4,687
5,083
5,860
6,298
5,460
5,001
4,536
4,313
7,658
6,441
9,521
73,369
CTP
268
466
428
873
462
469
690
1,223
4,387
677
314
306
10,563
ACA
2
17
201
39
3
2
1
6
3
12
0
2
288
GDUFA
24
14
10
24
924
103
40
19
8
13
34
36
1,249
CFSAN
148
174
144
116
183
176
231
276
170
181
182
179
2,160
HC
2,238
2,424
2,817
2,553
2,655
2,964
3,130
2,744
3,105
3,384
3,473
3,680
35,167
Totals
510,035
453,105
481,387
454,480
409,154
464,349
491,605
431,107
483,279
501,318
504,881
543,306
5,728,006
FDA ESG 2020 Monthly Acknowledgement Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
204,918
180,498
186,259
184,920
173,310
182,363
194,758
172,313
182,097
185,758
180,080
197,229
2,224,503
CDER
39,540
38,794
43,548
44,046
41,232
44,316
45,352
41,206
44,794
46,736
42,282
46,722
518,568
CBER
12,650
10,954
13,776
12,844
9,970
10,002
12,132
10,972
11,440
13,012
13,180
18,158
149,090
CDRH
784,152
701,592
752,292
676,854
578,979
710,508
751,449
649,998
759,324
797,979
839,562
878,634
8,881,323
CVM
12,894
12,174
14,038
12,064
13,450
17,634
17,058
14,470
15,942
15,536
13,544
14,070
172,874
OC
17,022
9,374
10,166
11,720
12,596
10,920
10,002
9,072
8,626
15,316
12,882
19,042
146,738
CTP
536
932
856
1,746
924
938
1,380
2,446
8,774
1,354
628
612
21,126
ACA
4
34
402
78
6
4
2
12
6
24
0
4
576
GDUFA
48
28
20
48
1,848
206
80
38
16
26
68
72
2,498
CFSAN
148
174
144
116
183
176
231
276
170
181
182
179
2,160
HC
4,476
4,848
5,634
5,106
5,310
5,928
6,260
5,488
6,210
6,768
6,946
7,360
70,334
Totals
1,076,388
959,402
1,027,135
949,542
837,808
982,995
1,038,704
906,291
1,037,399
1,082,690
1,109,354
1,182,082
12,189,790
FDA ESG 2020 Monthly Total Traffic Statistics
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Totals
AERS
409,836
360,996
372,518
369,840
346,620
364,726
389,516
344,626
364,194
371,516
360,160
394,458
4,449,006
CDER
59,310
58,191
65,322
66,069
61,848
66,474
68,028
61,809
67,191
70,104
63,423
70,083
777,852
CBER
18,975
16,431
20,664
19,266
14,955
15,003
18,198
16,458
17,160
19,518
19,770
27,237
223,635
CDRH
1,045,536
935,456
1,003,056
902,472
771,972
947,344
1,001,932
866,664
1,012,432
1,063,972
1,119,416
1,171,512
11,841,764
CVM
19,341
18,261
21,057
18,096
20,175
26,451
25,587
21,705
23,913
23,304
20,316
21,105
259,311
OC
25,533
14,061
15,249
17,580
18,894
16,380
15,003
13,608
12,939
22,974
19,323
28,563
220,107
CTP
804
1,398
1,284
2,619
1,386
1,407
2,070
3,669
13,161
2,031
942
918
31,689
ACA
6
51
603
117
9
6
3
18
9
36
0
6
864
GDUFA
72
42
30
72
2,772
309
120
57
24
39
102
108
3,747
CFSAN
296
348
288
232
366
352
462
552
340
362
364
358
4,320
HC
6,714
7,272
8,451
7,659
7,965
8,892
9,390
8,232
9,315
10,152
10,419
11,040
105,501
Totals
1,586,423
1,412,507
1,508,522
1,404,022
1,246,962
1,447,344
1,530,309
1,337,398
1,520,678
1,584,008
1,614,235
1,725,388
17,917,796
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Content current as of:
08/06/2021