Submission Statistics

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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	2,085,702	16,319,689
CDER	93,503	107,681	124,232	139,322	159,515	165,932	189,141	221,471	236,584	259,284	258,228	1,954,893
CBER	6397	6,927	8,412	9,506	11,294	20,278	52,197	56,044	70,900	74,545	642,437	958,937
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	3,424,279	19,062,018
CVM	20,462	37,928	40,978	44,607	52,601	64,197	70,436	70,682	74,750	86,437	81,673	644,751
OC	55,676	64,285	65,430	68,171	60,943	56,517	71,545	77,353	76,549	73,369	51,677	721,515
CTP	348	642	1,237	324	734	612	23,984	19,142	3,698	10,563	4,899	66,183
ACA		62	207	195	212	228	218	236	271	288	228	2,145
GDUFA		2,771	2,926	3,547	2,906	1,644	1,600	1,455	1,305	1,249	576	19,979
CFSAN		458	4,220	2,756	3,761	3,619	2,661	2,421	2,261	2,160	6,029	30,346
HC			324	5,835	9,366	16,497	23,595	26,927	27,302	35,167	33,521	178,534
ORA											53	53
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	6,589,302	39,959,043

**FDA ESG 2021 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Totals
AERS	182,833	185,634	198,270	183,702	200,409	184,877	219,943	193,590	191,144	169,348	175,952	2,085,702
CDER	19,068	20,894	24,711	23,577	23,440	24,812	23,754	23,795	24,783	25,164	24,230	258,228
CBER	18,930	26,675	31,183	46,014	46,600	56,094	71,441	137,355	75,191	66,984	65,970	642,437
CDRH	323,386	252,371	332,767	288,054	269,252	324,867	339,939	381,403	268,729	323,952	319,559	3,424,279
CVM	5,910	5,890	7,728	6,752	7,498	8,592	7,783	8,526	7,330	7,676	7,988	81,673
OC	5,649	4,004	5,004	4,988	3,856	4,794	4,389	3,802	3,529	5,792	5,870	51,677
CTP	420	498	523	334	375	691	484	432	644	252	246	4,899
ACA	6	23	158	19	5	1	1	7	1	2	5	228
GDUFA	19	21	25	32	263	92	33	23	18	25	25	576
CFSAN	175	190	3,869	248	196	254	213	215	191	247	231	6,029
HC	3,157	3,259	211	3,236	3,231	3,619	3,589	3,310	3,257	3,308	3,344	33,521
ORA				3	5	3	15	9	1	9	8	53
Totals	559,553	499,459	604,449	556,959	555,130	608,696	671,584	752,467	574,818	602,759	603,428	6,589,302

**FDA ESG 2021 Monthly Acknowledgement Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Totals
AERS	182,833	185,634	198,270	183,702	200,409	184,877	219,943	193,590	191,144	169,348	175,952	2,085,702
CDER	38,136	41,788	49,422	47,154	46,880	49,624	47,508	47,590	49,566	50,328	48,460	516,456
CBER	37,860	53,350	62,366	92,028	93,200	112,188	142,882	274,710	150,382	133,968	131,940	1,284,874
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	10,272,837
CVM	11,820	11,780	15,456	13,504	14,996	17,184	15,566	17,052	14,660	15,352	15,976	163,346
OC	11,298	8,008	10,008	9,976	7,712	9,588	8,778	7,604	7,058	11,584	11,740	103,354
CTP	840	996	1,046	668	750	1,382	968	864	1,288	504	492	9,798
ACA	12	46	316	38	10	2	2	14	2	4	10	456
GDUFA	38	42	50	64	526	184	66	46	36	50	50	1,152
CFSAN	175	190	3,869	248	196	254	213	215	191	247	231	6,029
HC	6,314	6,518	422	6,472	6,462	7,238	7,178	6,620	382	494	462	48,562
ORA				3	5	3	15	9	1	9	8	53
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	14,492,619

**FDA ESG 2021 Monthly Total Traffic Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Totals
AERS	365,666	371,268	396,540	367,404	400,818	369,754	439,886	387,180	382,288	338,696	351,904	4,171,404
CDER	57,204	62,682	74,133	70,731	70,320	74,436	71,262	71,385	74,349	75,492	72,690	774,684
CBER	56,790	80,025	93,549	138,042	139,800	168,282	214,323	412,065	225,573	200,952	197,910	1,927,311
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	13,697,116
CVM	17,730	17,670	23,184	20,256	22,494	25,776	23,349	25,578	21,990	23,028	23,964	245,019
OC	16,947	12,012	15,012	14,964	11,568	14,382	13,167	11,406	10,587	17,376	17,610	155,031
CTP	1,260	1,494	1,569	1,002	1,125	2,073	1,452	1,296	1,932	756	738	14,697
ACA	18	69	474	57	15	3	3	21	3	6	15	684
GDUFA	57	63	75	96	789	276	99	69	54	75	75	1,728
CFSAN	350	380	7,738	496	392	508	426	430	382	494	462	12,058
HC	9,471	9,777	633	9,708	9,693	10,857	10,767	9,930	573	741	693	72,843
ORA				6	10	6	30	18	2	18	16	106
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	21,072,681

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

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

201

288

GDUFA

924

103

1,249

CFSAN

148

174

144

116

183

176

231

276

170

181

182

179

2,160

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