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Submission Statistics Archives

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**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

**FDA ESG 2019 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	181,081	184,222	173,881	184,934	180,281	173,129	227,099	175,299	170,006	166,754	160,326	183,008	2,160,020
CDER	19,240	18,243	17,909	20,252	21,024	19,132	20,347	20,369	19,500	21,441	19,031	20,096	236,584
CBER	5,820	5,041	5,526	5,189	6,015	5,215	6,782	6,500	5,548	5,979	6,514	6,771	70,900
CDRH	236,293	198,378	227,468	210,646	196,542	191,825	209,244	239,956	330,931	247,397	242,205	243,967	2,774,852
CVM	5,704	5,305	5,436	5,833	6,662	6,511	7,351	6,653	6,313	6,861	6,094	6,027	74,750
OC	6,283	4,987	6,038	4,442	4,305	4,226	3,728	4,318	5,805	9,168	10,013	13,236	76,549
CTP	235	182	230	317	312	483	276	396	430	284	202	351	3,698
ACA	8	21	184	34	7	4	6	2	2	1	1	1	271
GDUFA	23	19	49	23	855	109	35	19	45	30	49	49	1,305
CFSAN	204	200	201	171	262	191	201	138	140	166	213	174	2,261
HC	2,376	2,059	2,252	2,256	2,352	2,273	2,721	2,308	2,032	2,282	2,237	2,154	27,302
Totals	457,267	418,657	439,174	434,097	418,617	403,098	477,790	455,958	540,752	460,363	446,885	475,834	5,428,492

**FDA ESG 2019 Monthly Acknowledgement Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	181,081	184,222	173,881	184,934	180,281	173,129	227,099	175,299	170,006	166,754	160,326	183,008	2,160,020
CDER	38,480	36,486	35,818	40,504	42,048	38,264	40,694	40,738	39,000	42,882	38,062	40,192	473,168
CBER	11,640	10,082	11,052	10,378	12,030	10,430	13,564	13,000	11,096	11,958	13,028	13,542	141,800
CDRH	708,879	595,134	682,404	631,938	589,626	575,475	627,732	719,868	992,793	742,191	726,615	731,901	8,324,556
CVM	11,408	10,610	10,872	11,666	13,324	13,022	14,702	13,306	12,626	13,722	12,188	12,054	149,500
OC	6,283	9,974	12,076	8,884	8,610	8,452	7,456	8,636	11,610	18,336	20,026	26,472	153,098
CTP	470	364	460	634	624	966	552	792	860	568	404	702	7,396
ACA	16	42	368	68	14	8	12	4	4	2	2	2	542
GDUFA	46	38	98	46	1,710	218	70	38	90	60	98	98	2,610
CFSAN	204	200	201	171	262	191	201	138	140	166	213	174	2,261
HC	4,752	4,118	4,504	4,512	4,704	4,546	5,442	4,616	4,064	4,564	4,474	4,308	54,604
Totals	969,542	851,270	931,734	893,735	853,233	824,701	937,524	976,435	1,242,289	1,001,203	975,436	1,012,453	11,469,555

**FDA ESG 2019 Monthly Total Traffic Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	362,162	368,444	347,762	369,868	360,562	346,258	454,198	350,598	340,012	333,508	320,652	366,016	4,320,040
CDER	57,720	54,729	53,727	60,756	63,072	57,396	61,041	61,107	58,500	64,323	57,093	60,288	709,752
CBER	17,460	15,123	16,578	15,567	18,045	15,645	20,346	19,500	16,644	17,937	19,542	20,313	212,700
CDRH	945,172	793,512	909,872	842,584	786,168	767,300	836,976	959,824	1,323,724	989,588	968,820	975,868	11,099,408
CVM	17,112	15,915	16,308	17,499	19,986	19,533	22,053	19,959	18,939	20,583	18,282	18,081	224,250
OC	18,849	14,961	18,114	13,326	12,915	12,678	11,184	12,954	17,415	27,504	30,039	39,708	229,647
CTP	705	546	690	951	936	1,449	828	1,188	1,290	852	606	1,053	11,094
ACA	24	63	552	102	21	12	18	6	6	3	3	3	813
GDUFA	69	57	147	69	2,565	327	105	57	135	90	147	147	3,915
CFSAN	408	400	402	342	524	382	402	276	280	332	426	348	4,522
HC	7,128	6,177	6,756	6,768	7,056	6,819	8,163	6,924	6,096	6,846	6,711	6,462	81,906
Totals	1,426,809	1,269,927	1,370,908	1,327,832	1,271,850	1,227,799	1,415,314	1,432,393	1,783,041	1,461,566	1,422,321	1,488,287	16,898,047

**FDA ESG 2018 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	193,303	155,234	168,917	189,439	187,585	182,567	199,129	170,493	160,190	178,549	173,019	160,402	2,118,827
CDER	17,149	20,811	18,210	17,312	18,739	19,156	17,931	19,766	17,354	18,564	18,364	18,115	221,471
CBER	3,227	3,535	3,479	3,348	3,503	4,706	6,022	5,582	4,799	6,661	5,562	5,620	56,044
CDRH	159,841	150,260	167,525	163,605	162,229	215,421	162,003	244,031	240,069	216,559	193,536	176,167	2,247,286
CVM	4,881	5,155	5,753	5,488	7,035	6,436	7,040	6,174	5,324	6,649	5,520	5,227	70,682
OC	7,137	4,729	4,744	4,824	5,262	4,802	4,174	4,795	4,123	7,721	9,607	15,435	77,353
CTP	123	274	139	972	2,015	215	106	269	437	7,293	6,946	353	19,142
MWP	0	0	0	0	0	0	0	0	0	0	0	0	0
ACA	0	9	170	34	3	3	2	7	3	2	1	2	236
GDUFA	44	11	20	19	945	161	75	35	28	36	44	37	1,455
CFSAN	261	184	221	208	212	199	248	193	132	164	207	192	2,421
HC	1,895	2,088	2,227	2,274	2,450	2,452	2,414	2,492	1,955	2,240	2,374	2,066	26,927
Totals	387,861	342,290	371,405	387,523	389,978	436,118	399,144	453,837	434,414	444,478	415,180	379,616	4,841,844

**FDA ESG 2018 Monthly Acknowledgement Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	193,303	155,234	168,917	189,439	187,585	182,567	199,129	170,493	160,190	178,549	173,019	160,402	2,118,827
CDER	34,298	41,622	36,420	34,624	37,478	38,312	35,862	39,532	34,708	37,128	36,728	36,230	442,942
CBER	3,227	3,535	3,479	3,348	3,503	4,706	6,022	5,582	4,799	13,322	11,124	11,240	73,887
CDRH	479,523	450,780	502,575	490,815	486,687	646,263	486,009	732,093	720,207	649,797	580,608	516,501	6,741,858
CVM	9,762	10,310	11,506	10,976	14,070	12,872	14,080	12,348	10,648	13,298	11,040	10,454	141,364
OC	14,274	9,458	9,488	9,648	10,524	9,604	8,348	9,590	8,246	15,442	19,214	15,435	139,271
CTP	246	548	278	1,944	4,030	430	212	538	874	14,586	13,892	706	38,284
MWP	0	0	0	0	0	0	0	0	0	0	0	0	0
ACA	0	9	170	34	3	3	2	7	3	2	1	4	238
GDUFA	44	11	20	19	945	161	75	35	28	36	44	74	1,492
CFSAN	261	184	221	208	212	199	248	193	132	164	207	192	2,421
HC	3,790	4,176	4,454	4,548	4,900	4,904	4,828	4,984	3,910	4,480	4,748	4,132	53,854
Totals	738,728	675,867	737,528	745,603	749,937	900,021	754,815	975,395	943,745	926,804	850,625	755,370	9,754,438

**FDA ESG 2018 Monthly Total Traffic Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	386,606	310,468	337,834	378,878	375,170	365,134	398,258	340,986	320,380	357,098	346,038	320,804	4,237,654
CDER	51,447	62,433	54,630	51,936	56,217	57,468	53,793	59,298	52,062	55,692	55,092	54,345	664,413
CBER	6,454	7,070	6,958	6,696	7,006	9,412	12,044	11,164	9,598	19,983	16,686	16,860	129,931
CDRH	639,364	601,040	670,100	654,420	648,916	861,684	648,012	976,124	960,276	866,396	774,144	688,668	8,989,144
CVM	14,643	15,465	17,259	16,464	21,105	19,308	21,120	18,522	15,972	19,947	16,560	15,681	212,046
OC	21,411	14,187	14,232	14,472	15,786	14,406	12,522	14,385	12,369	23,163	28,821	30,870	216,624
CTP	369	822	417	2,916	6,045	645	318	807	1,311	21,879	20,838	1,059	57,426
MWP	0	0	0	0	0	0	0	0	0	0	0	0	0
ACA	0	18	340	68	6	6	4	14	6	4	2	6	474
GDUFA	88	22	40	38	1,890	322	150	70	56	72	88	111	2,947
CFSAN	522	368	442	416	424	398	496	386	264	328	414	384	4,842
5,865	5,685	6,264	6,681	6,822	7,350	7,356	7,242	7,476	5,865	6,720	7,122	6,198	80,781
Totals	1,126,589	1,018,157	1,108,933	1,133,126	1,139,915	1,336,139	1,153,959	1,429,232	1,378,159	1,371,282	1,265,805	1,134,986	14,596,282

**FDA ESG 2017 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	132,260	139,651	148,193	133,979	140,483	143,564	145,394	147,858	134,031	161,900	126,763	144,018	1,698,094
CDER	13,896	14,315	16,690	14,392	16,468	17,334	14,563	16,978	16,238	16,026	16,198	16,043	189,141
CBER	3,907	4,251	4,476	4,381	6,095	4,265	4,186	5,086	4,625	4,490	3,507	2,928	52,197
CDRH	134,720	135,026	147,500	132,215	137,605	160,925	142,492	147,453	292,757	185,161	156,804	149,213	1,921,871
CVM	4,883	4,254	5,786	7,000	6,716	6,734	6,360	6,793	5,479	6,225	5,583	4,623	70,436
OC	4,815	4,578	4,323	4,052	4,709	4,885	4,064	4,316	3,704	6,758	9,434	15,907	71,545
CTP	155	1,179	16,537	165	233	420	386	407	306	1,505	2,488	203	23,984
MWP	0	0	0	0	0	0	0	0	0	0	0	0	0
ACA	7	10	149	31	7	2	3	1	3	1	1	3	218
GDUFA	37	11	22	25	1,118	127	53	23	33	50	49	52	1,600
CFSAN	197	211	231	201	302	344	205	196	150	261	190	173	2,661
HC	1,579	1,729	2,145	1,878	2,076	2,050	2,110	2,041	1,879	2,062	2,108	1,938	23,595
Totals	296,456	305,215	346,052	298,319	315,812	340,650	319,816	331,152	459,205	384,439	323,125	335,101	4,055,342

**FDA ESG 2017 Monthly Acknowledgement Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	132,260	139,651	148,193	133,979	140,483	143,564	145,394	147,858	134,031	161,900	126,763	144,018	1,698,094
CDER	27,792	28,630	33,380	28,784	32,936	34,668	29,126	33,956	32,476	32,052	32,396	32,086	378,282
CBER	3,907	4,251	4,476	4,381	6,095	4,265	4,186	5,086	4,625	4,490	3,507	2,928	52,197
CDRH	404,160	405,078	442,500	396,645	412,815	482,775	427,476	442,359	878,271	555,483	470,412	447,639	5,765,613
CVM	9,766	8,508	11,572	14,000	13,432	13,468	12,720	13,586	10,958	12,450	11,166	9,246	140,872
OC	9,630	9,156	8,646	8,104	9,418	9,770	8,128	8,632	7,408	13,516	18,868	31,814	143,090
CTP	310	2,358	33,074	330	466	840	772	814	612	3,010	4,976	406	47,968
MWP	0	0	0	0	0	0	0	0	0	0	0	0	0
ACA	7	10	149	31	7	2	3	1	3	1	1	3	218
GDUFA	37	11	22	25	1,118	127	53	23	33	50	49	52	1,600
CFSAN	197	211	231	201	302	344	205	196	150	261	190	173	2,661
HC	3,158	3,458	4,290	3,756	4,152	4,100	4,220	4,082	3,758	4,124	4,216	3,876	47,190
Totals	591,224	601,322	686,533	590,236	621,224	693,923	632,283	656,593	1,072,325	787,337	672,544	672,241	8,277,785

**FDA ESG 2017 Monthly Total Traffic Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	264,520	279,302	296,386	267,958	280,966	287,128	290,788	295,716	268,062	323,800	253,526	288,036	3,396,188
CDER	41,688	42,945	50,070	43,176	49,404	52,002	43,689	50,934	48,714	48,078	48,594	48,129	567,423
CBER	7,814	8,502	8,952	8,762	12,190	8,530	8,372	10,172	9,250	8,980	7,014	5,856	104,394
CDRH	538,880	540,104	590,000	528,860	550,420	643,700	569,968	589,812	1,171,028	740,644	627,216	596,852	7,687,484
CVM	14,649	12,762	17,358	21,000	20,148	20,202	19,080	20,379	16,437	18,675	16,749	13,869	211,308
OC	14,445	13,734	12,969	12,156	14,127	14,655	12,192	12,948	11,112	20,274	28,302	47,721	214,635
CTP	465	3,537	49,611	495	699	1,260	1,158	1,221	918	4,515	7,464	609	71,952
MWP	0	0	0	0	0	0	0	0	0	0	0	0	0
ACA	14	20	298	62	14	4	6	2	6	2	2	6	436
GDUFA	74	22	44	50	2,236	254	106	46	66	100	98	104	3,200
CFSAN	394	422	462	402	604	688	410	392	300	522	380	346	5,322
HC	4,737	5,187	6,435	5,634	6,228	6,150	6,330	6,123	5,637	6,186	6,324	5,814	70,785
Totals	887,680	906,537	1,032,585	888,555	937,036	1,034,573	952,099	987,745	1,531,530	1,171,776	995,669	1,007,342	12,333,127

**FDA ESG 2016 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	131,928	181,075	124,552	118,835	123,781	123,487	119,245	125,029	120,565	124,496	118,465	121,920	1,533,378
CDER	11,836	14,283	15,033	14,046	14,088	14,537	12,256	13,964	14,018	13,246	13,705	14,920	165,932
CBER	909	1,146	1,461	1,459	1,321	1,418	1,510	1,643	1,706	1,770	1,902	4,033	20,278
CDRH	102,904	105,441	121,011	144,773	129,037	146,535	179,350	230,948	359,327	235,412	135,945	142,084	2,032,767
CVM	3,836	3,904	4,836	5,435	6,498	6,062	5,163	6,542	5,544	5,531	5,585	4,468	63,404
OC	4,396	4,221	4,424	3,920	4,250	4,452	4,015	4,362	4,352	6,455	5,413	6,257	56,517
CTP	22	96	21	22	40	67	26	64	45	35	36	138	612
MWP	147	369	195	82	0	0	0	0	0	0	0	0	793
ACA	6	7	128	60	14	2	3	1	1	3	3	0	228
GDUFA	14	21	21	36	1,115	199	59	36	40	35	37	31	1,644
CFSAN	241	321	313	307	470	517	327	202	181	205	250	285	3,619
HC	976	1,224	1,443	1,336	1,244	1,465	1,389	1,407	1,393	1,355	1,596	1,669	16,497
Totals	257,215	312,108	273,438	290,311	281,858	298,741	323,343	384,198	507,172	388,543	282,937	295,805	3,895,669

**FDA ESG 2016 Monthly Acknowledgement Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	131,928	181,075	124,552	118,835	123,781	123,487	119,245	125,029	120,565	124,496	118,465	121,920	1,533,378
CDER	11,836	14,283	15,033	14,046	14,088	29,074	24,512	27,928	28,036	26,492	27,410	29,840	262,578
CBER	909	1,146	1,461	1,459	1,321	1,418	1,510	1,643	1,706	1,770	1,902	4,033	20,278
CDRH	308,712	316,323	363,033	434,319	387,111	439,605	538,050	692,844	1,077,981	706,236	407,835	426,252	6,098,301
CVM	7,672	7,808	9,672	10,870	12,996	12,124	10,326	13,084	11,088	11,062	11,170	8,936	126,808
OC	8,792	8,442	8,848	7,840	8,500	8,904	8,030	8,724	8,704	12,910	10,826	12,514	113,034
CTP	44	192	42	44	80	134	52	128	90	70	72	276	1,224
MWP	147	369	195	82	0	0	0	0	0	0	0	0	793
ACA	6	7	128	60	14	2	3	1	1	3	3	0	228
GDUFA	14	21	21	36	1,115	199	59	36	40	35	37	31	1,644
CFSAN	241	321	313	307	470	517	327	202	181	205	250	285	3,619
HC	976	1,224	1,443	1,336	1,244	1,465	2,778	2,814	2,786	2,710	3,192	3,338	25,306
Totals	471,277	531,211	524,741	589,234	550,720	616,929	704,892	872,433	1,251,178	885,989	581,162	607,425	8,187,191

**FDA ESG 2016 Monthly Total Traffic Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	263,856	362,150	249,104	237,670	247,562	246,974	238,490	250,058	241,130	248,992	236,930	243,840	3,066,756
CDER	23,672	28,566	30,066	28,092	28,176	43,611	36,768	41,892	42,054	39,738	41,115	44,760	428,510
CBER	1,818	2,292	2,922	2,918	2,642	2,836	3,020	3,286	3,412	3,540	3,804	8,066	40,556
CDRH	411,616	421,764	484,044	579,092	516,148	586,140	717,400	923,792	1,437,308	941,648	543,780	568,336	8,131,068
CVM	11,508	11,712	14,508	16,305	19,494	18,186	15,489	19,626	16,632	16,593	16,755	13,404	190,212
OC	13,188	12,663	13,272	11,760	12,750	13,356	12,045	13,086	13,056	19,365	16,239	18,771	169,551
CTP	66	288	63	66	120	201	78	192	135	105	108	414	1,836
MWP	294	738	390	164	0	0	0	0	0	0	0	0	1,586
ACA	12	14	256	120	28	4	6	2	2	6	6	0	456
GDUFA	28	42	42	72	2,230	398	118	72	80	70	74	62	3,288
CFSAN	482	642	626	614	940	1,034	654	404	362	410	500	570	7,238
HC	1,952	2,448	2,886	2,672	2,488	2,930	4,167	4,221	4,179	4,065	4,788	5,007	41,803
Totals	728,492	843,319	798,179	879,545	832,578	915,670	1,028,235	1,256,631	1,758,350	1,274,532	864,099	903,230	12,082,860

**FDA ESG 2015 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	82,917	160,010	110,496	93,227	84,451	96,088	108,442	121,632	125,138	119,059	100,956	118,698	1,321,114
CDER	11,232	12,242	13,696	13,586	12,938	13,513	14,171	12,777	13,939	13,779	12,948	14,694	159,515
CBER	819	753	858	865	807	925	1,072	956	945	1,092	1,070	1,132	11,294
CDRH	70,932	71,922	76,133	85,850	72,520	107,745	131,966	192,085	205,481	224,725	126,921	112,244	1,478,524
CVM	3,129	3,286	3,554	4,308	4,435	4,758	4,920	4,343	5,792	4,366	3,913	3,934	50,738
OC	5,382	4,648	4,708	5,192	4,625	5,307	4,368	4,211	4,376	6,374	5,135	6,617	60,943
CTP	20	71	17	81	141	32	32	43	59	103	76	59	734
MWP	92	83	101	133	181	132	95	87	347	229	211	172	1,863
ACA	4	18	118	54	12	1	2	0	1	0	0	2	212
GDUFA	89	79	97	78	2,127	182	67	40	36	36	33	42	2,906
CFSAN	462	418	435	342	253	258	282	296	275	294	253	193	3,761
HC	724	630	753	651	706	708	1,125	804	734	804	866	861	9,366
Totals	175,802	254,160	210,966	204,367	183,196	229,649	266,542	337,274	357,123	370,861	252,382	258,648	3,100,970

**FDA ESG 2015 Monthly Acknowledgement Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	82,921	160,008	110,499	93,229	84,451	96,088	108,442	121,632	125,138	119,059	100,956	118,698	1,321,121
CDER	11,232	12,242	13,696	13,586	12,938	13,513	14,171	12,777	13,939	13,779	12,948	14,694	159,515
CBER	819	753	858	865	807	925	1,072	956	945	1,092	1,070	1,132	11,294
CDRH	212,730	215,655	228,555	257,598	217,560	323,235	395,898	576,255	616,443	674,175	380,763	336,732	4,435,599
CVM	6,258	6,572	7,108	8,616	8,870	9,516	9,840	8,686	11,584	8,732	7,826	7,868	101,476
OC	5,380	4,650	4,706	5,194	4,625	5,307	4,368	4,211	4,376	6,374	5,135	6,617	60,943
CTP	40	142	34	162	282	64	64	86	118	206	152	118	1,468
MWP	92	83	101	133	181	132	95	87	347	229	211	172	1,863
ACA	4	18	118	54	12	1	2	0	1	0	0	2	212
GDUFA	89	79	97	78	2,127	182	67	40	36	36	33	42	2,906
CFSAN	462	418	435	342	253	88	88	296	275	294	253	193	3,397
HC	724	630	753	651	706	708	1,125	804	734	804	866	861	9,366
Totals	320,751	401,250	366,960	380,508	332,812	449,759	535,232	725,830	773,936	824,780	510,213	487,129	6,109,160

**FDA ESG 2015 Monthly Total Traffic Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	165,842	320,016	220,998	186,458	168,902	192,176	216,884	243,264	250,276	238,118	201,912	237,396	2,642,242
CDER	22,464	24,484	27,392	27,172	25,876	27,026	28,342	25,554	27,878	27,558	25,896	29,388	319,030
CBER	1,638	1,506	1,716	1,730	1,614	1,850	2,144	1,912	1,890	2,184	2,140	2,264	22,588
CDRH	283,640	287,540	304,740	343,464	290,080	430,980	527,864	768,340	821,924	898,900	507,684	448,976	5,914,132
CVM	9,387	9,858	10,662	12,924	13,305	14,274	14,760	13,029	17,376	13,098	11,739	11,802	152,214
OC	10,760	9,300	9,412	10,388	9,250	10,614	8,736	8,422	8,752	12,748	10,270	13,234	121,886
CTP	60	213	51	243	423	96	96	129	177	309	228	177	2,202
MWP	184	166	202	266	362	264	190	174	694	458	422	344	3,726
ACA	8	36	236	108	24	2	4	0	2	0	0	4	424
GDUFA	178	158	194	156	4,254	364	134	80	72	72	66	84	5,812
CFSAN	924	836	870	684	506	176	176	592	550	588	506	386	6,794
HC	1,448	1,260	1,506	1,302	1,412	1,416	2,250	1,608	1,468	1,608	1,732	1,722	18,732
Totals	496,533	655,373	577,979	584,895	516,008	679,238	801,580	1,063,104	1,131,059	1,195,641	762,595	745,777	9,209,782

**FDA ESG 2014 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	77,484	88,356	118,217	104,996	70,062	73,729	103,209	73,588	77,413	87,268	69,347	82,645	1,026,314
CDER	10,242	10,760	11,293	11,293	11,495	12,270	12,388	11,840	11,741	12,295	11,036	12,669	139,322
CBER	630	750	762	845	792	795	857	783	830	929	718	815	9,506
CDRH	60,364	69,384	65,000	68,372	54,327	60,037	64,162	67,556	85,670	79,260	62,015	76,296	812,443
CVM	2,484	2,439	2,772	3,383	3,533	3,758	4,454	4,279	4,230	4,813	3,539	4,092	43,776
OC	6,049	4,751	5,137	5,998	5,515	5,280	5,146	4,818	4,773	8,202	5,445	7,057	68,171
CTP	30	37	28	38	24	18	27	31	21	23	26	21	324
MWP	45	57	57	78	63	77	93	77	74	76	72	26	831
ACA	7	11	96	45	10	13	6	4	0	1	1	1	195
GDUFA	113	96	46	177	2,276	260	108	135	104	90	62	80	3,547
CFSAN	182	147	253	220	337	239	226	199	240	181	239	293	2,756
HC	195	310	364	399	445	477	781	643	518	569	570	564	5,835
Totals	157,825	177,098	204,025	195,844	148,879	156,953	191,457	163,953	185,614	193,707	153,070	184,595	2,113,020

**FDA ESG 2014 Monthly Acknowledgement Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	77,484	88,356	118,217	104,996	70,062	73,729	103,209	73,588	77,413	87,268	69,347	82,645	1,026,314
CDER	10,242	10,760	11,293	11,293	11,495	12,270	12,388	11,840	11,741	12,295	11,036	12,669	139,322
CBER	630	750	762	845	792	795	857	783	830	929	718	815	9,506
CDRH	181,092	208,152	195,000	205,116	162,981	180,111	192,486	202,668	257,010	237,780	186,045	228,888	2,437,329
CVM	4,968	4,878	5,544	6,766	7,066	7,516	8,908	8,558	8,460	9,626	7,078	8,184	87,552
OC	6,049	4,751	5,137	5,998	5,515	5,280	5,146	4,818	4,773	8,202	5,445	7,057	68,171
CTP	60	74	56	76	48	36	54	62	42	46	52	42	648
MWP	45	57	57	78	63	77	93	77	74	76	72	62	831
ACA	7	11	96	45	10	13	6	4	0	1	1	1	195
GDUFA	113	96	46	177	2,276	260	108	135	104	90	62	80	3,547
CFSAN	182	147	253	220	337	239	226	198	240	182	239	293	2,756
HC	195	310	364	399	445	477	781	643	518	569	570	564	5,835
Totals	280,885	318,342	336,825	336,009	261,090	280,803	324,262	303,374	361,205	357,064	280,665	341,300	3,782,006

**FDA ESG 2014 Monthly Total Traffic Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	154,968	176,712	236,434	209,992	140,124	147,458	206,418	147,176	154,826	174,536	138,694	165,290	2,052,628
CDER	20,484	21,520	22,586	22,586	22,990	24,540	24,776	23,680	23,482	24,590	22,072	25,338	278,644
CBER	1,260	1,500	1,524	1,690	1,584	1,590	1,714	1,566	1,660	1,858	1,436	1,630	19,012
CDRH	241,456	277,536	260,000	273,488	217,308	240,148	256,648	270,224	342,680	317,040	248,060	305,184	3,249,772
CVM	7,452	7,317	8,316	10,149	10,599	11,274	13,362	12,837	12,690	14,439	10,617	12,276	131,328
OC	12,098	9,502	10,274	11,996	11,030	10,560	10,292	9,636	9,546	16,404	10,890	14,114	136,342
CTP	90	111	84	114	72	54	81	93	63	69	78	63	972
MWP	90	114	114	156	126	154	186	154	148	152	144	124	1,662
ACA	14	22	192	90	20	26	12	8	0	2	2	2	390
GDUFA	226	192	92	354	4,552	520	216	270	208	180	124	160	7,094
CFSAN	364	294	506	440	674	478	452	398	480	362	478	586	5,512
HC	390	620	728	728	890	954	1,562	1,286	1,036	1,138	1,140	1,128	11,670
Totals	438,892	495,440	540,850	531,853	409,969	437,756	515,719	467,328	546,819	550,770	433,735	525,895	5,895,026

**FDA ESG 2013 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	93,365	61,638	63,671	66,882	65,284	64,807	68,039	69,495	67,313	111,469	72,206	72,306	876,475
CDER	9,095	9,657	10,199	10,914	11,212	10,322	10,635	10,291	9,807	11,221	9,944	10,935	124,232
CBER	619	566	654	680	736	667	791	764	780	811	658	686	8,412
CDRH	45,044	45,463	42,220	59,465	51,914	61,173	63,190	65,249	53,316	68,704	52,942	58,247	666,927
CVM	2,403	3,608	2,612	4,396	3,678	4,396	3,254	3,012	3,507	3,401	3,125	2,849	40,241
OC	6,931	4,532	4,400	4,785	5,154	4,699	4,935	5,377	4,405	6,808	5,860	7,544	65,430
CTP	203	49	38	92	257	157	126	109	126	20	6	54	1,237
MWP	61	54	44	55	56	82	57	57	56	75	79	61	737
ACA	0	9	47	67	33	11	20	4	6	1	6	3	207
GDUFA	0	123	100	71	1,952	126	73	85	117	98	95	86	2,926
CFSAN	320	232	234	237	180	129	143	178	211	1,621	313	163	4,220
HC											154	170	324
Totals	158,041	125,931	124,219	147,644	140,456	146,569	151,263	154,621	139,644	204,229	145,388	153,104	1,791,368

**FDA ESG 2013 Monthly Acknowledgement Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	93,365	61,638	63,671	66,882	65,284	64,807	68,039	69,495	67,313	111,469	72,206	72,306	876,475
CDER	9,095	9,657	10,199	10,914	11,212	10,322	10,635	10,291	9,807	11,221	9,944	10,935	124,232
CBER	619	566	654	680	736	667	791	764	780	811	658	686	8,412
CDRH	135,132	136,389	126,660	178,395	155,742	183,519	189,570	195,747	159,948	206,112	158,826	174,741	2,000,781
CVM	4,806	7,216	5,224	8,792	7,356	8,792	6,508	6,024	7,014	6,802	6,250	5,698	80,482
OC	6,931	4,532	4,400	4,785	5,154	4,699	4,935	5,377	4,405	6,808	5,860	7,544	65,430
CTP	609	147	114	276	771	471	378	218	252	40	12	108	3,396
MWP	61	54	44	55	56	82	57	57	56	75	79	61	737
ACA	0	9	47	67	33	11	20	4	6	1	6	3	207
GDUFA	0	123	100	71	1,952	126	73	85	117	98	95	86	2,926
CFSAN	320	232	234	237	180	129	143	178	211	1,621	313	163	4,220
HC											154	170	324
Totals	250,938	220,563	211,347	271,154	248,476	273,625	281,149	288,240	249,909	345,058	254,403	272,501	3,167,622

**FDA ESG 2013 Monthly Total Traffic Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	186,730	123,276	127,342	133,764	130,568	129,614	136,078	138,990	134,626	222,938	144,412	144,612	1,752,950
CDER	18,190	19,314	20,398	21,828	22,424	20,644	21,270	20,582	19,614	22,442	19,888	21,870	248,464
CBER	1,236	1,132	1,308	1,360	1,472	1,334	1,582	1,528	1,560	1,622	1,316	1,372	16,824
CDRH	180,176	181,852	168,880	237,860	207,656	244,692	252,760	260,996	213,264	274,816	211,768	232,988	2,667,708
CVM	7,209	10,824	7,836	13,188	11,034	13,188	9,762	9,036	10,521	10,203	9,375	8,547	120,723
OC	13,862	9,064	8,800	9,570	10,308	9,398	9,870	10,754	8,810	13,616	11,720	15,088	130,860
CTP	812	196	152	368	1,028	628	504	327	378	60	18	162	4,633
MWP	122	108	88	110	112	164	114	114	112	150	158	122	1,474
ACA	0	18	94	134	66	22	40	8	12	2	12	6	414
GDUFA	0	246	200	142	3,904	252	146	170	234	196	190	172	5,852
CFSAN>	640	464	0	474	360	258	286	356	422	3,242	626	326	7,454
HC											308	340	648
Totals	408,979	346,494	335,098	418,798	388,932	420,194	432,412	442,861	389,553	549,287	399,791	425,605	4,958,004

**FDA ESG 2012 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	68,102	52,381	52,626	51,151	57,520	54,137	53,453	66,626	61,277	77,909	65,465	56,698	717,345
CDER	7,455	8,054	9,465	8,588	9,250	8,815	8,324	10,366	9,079	8,971	10,245	9,069	107,681
CBER	470	518	595	594	607	563	636	621	534	598	573	618	6,927
CDRH	36,669	38,843	53,236	41,056	35,871	34,657	38,248	37,727	33,208	40,840	35,545	36,416	462,316
CVM	3,376	4,048	2,659	2,633	2,905	2,854	3,126	3,690	2,345	2,632	2,631	2,530	35,429
OC	6,649	4,804	5,101	5,023	5,093	5,102	4,687	5,906	4,790	6,206	5,450	5,474	64,285
CTP	79	7	3	37	131	45	25	64	102	27	35	87	642
MWP	272	344	616	287	>586	56	44	58	42	>56	75	63	2,499
ACA									32	21	6	3	62
GDUFA									36	633	1409	93	2,771
CFSAN											260	198	458
Totals	123,072	108,999	124,301	109,369	111,963	106,229	108,543	125,058	111,445	137,893	121,694	111,849	1,400,415

**FDA ESG 2011 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	47,160	37,282	47,739	42,665	45,939	49,654	40,094	54,154	40,695	50,217	56,387	45,931	557,917
CDER	6,320	7,248	8,213	7,649	8,008	8,251	7,686	8,364	7,999	7,858	7,902	8,005	93,503
CBER	396	476	605	466	536	574	534	611	533	530	562	574	6,937
CDRH	20,194	13,374	17,275	21,680	19,567	20,075	27,478	24,501	26,522	32,546	29,427	27,673	280,312
CVM	280	444	562	516	714	674	565	2,920	3,498	3,240	2,827	1,692	17,932
OC	5,758	4,041	4,638	4,380	4,645	5,726	4,651	4,616	3,974	3,861	4,451	4,935	55,676
CTP	26	12	24	6	10	24	7	3	17	18	136	65	348
MWP	160	171	183	164	190	165	112	200	191	266	354	374	2,530
Totals	80,294	63,048	79,239	77,526	79,609	85,143	81,127	95,369	83,429	98,536	102,046	89,249	1,014,615

**FDA ESG 2010 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	28,801	28,889	31,713	27,601	27,305	38,697	67,085	47,587	42,622	35,510	40,007	57,045	472,142
CDER	4,171	4,660	5,798	5,581	5,639	6,136	5,696	6,195	5,980	6,279	6,485	7,119	69,739
CBER	361	427	535	457	399	555	502	477	449	476	441	509	5,588
CDRH	3,465	6,108	6,904	7,153	6,217	8,183	13,590	12,097	10,620	18,096	11,905	14,749	119,087
CVM	78	106	73	93	59	90	67	77	51	67	74	110	945
OC	3,904	3,906	4,114	3,649	3,745	5,767	4,301	4,499	3,519	3,415	3,457	4,766	48,232
CTP	1	23	6	14	3	61	20	17	20	9	6	43	223
MWP					106	157	106	176	130	119	114	230	1,138
Totals	40,061	43,309	49,143	44,548	43,473	59,646	91,367	71,125	63,391	63,971	62,489	84,571	717,094

**FDA ESG 2009 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	19,261	21,031	26,581	22,152	22,569	26,240	24,224	29,097	30,467	25,240	25,480	28,330	300,672
CDER	2,268	2,998	3,235	3,408	3,493	3,692	3,989	4,075	4,182	4,758	4,552	4,860	45,510
CBER	257	261	341	338	290	362	363	352	365	479	517	558	4,483
CDRH	700	812	1,642	1,554	1,361	1,345	1,694	1,339	2,448	2,529	3,299	2,573	21,296
CVM	60	73	103	103	70	70	96	68	58	46	55	57	859
OC	63	70	102	96	85	840	969	1,416	1,852	2,640	2,971	5,171	16,275
CTP												5	5
Totals	22,609	25,245	32,004	27,651	27,868	32,549	31,335	36,347	39,372	35,692	36,874	41,554	389,100

**FDA ESG 2008 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	15,325	17,882	25,760	21,631	18,703	21,966	19,359	21,527	22,691	20,001	19,170	28,599	252,614
CDER	1,397	1,720	1,644	1,695	1,747	1,783	2,121	2,328	2,375	2,718	2,413	2,856	24,797
CBER	153	195	168	203	194	220	301	201	223	239	177	283	2,557
CDRH	115	147	144	212	246	279	257	387	451	939	403	1,039	4,619
CVM	62	64	70	78	63	101	83	90	41	69	50	72	843
OC							2	15	18	24	27	102	188
Totals	17,052	20,008	27,786	23,819	20,953	24,349	22,123	24,548	25,799	23,990	22,240	32,951	285,618

**FDA ESG 2007 Monthly Submission Statistics**
	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	9,576	9,948	12,158	14,696	12,917	15,177	12,546	12,906	14,925	14,810	13,568	16,335	159,562
CDER	457	600	650	785	1,009	950	880	1,132	930	1,212	1,258	1,312	11,175
CBER	68	58	85	102	101	106	119	193	149	179	181	163	1,504
CDRH	176	108	127	102	75	138	80	205	267	118	70	61	1,527
CVM							45	58	35	55	46	49	288
OC
Totals	10,277	10,714	13,020	15,685	14,102	16,371	13,670	14,494	16,306	16,374	15,123	17,920	174,056

**FDA ESG 2006 Monthly Submission Statistics**
	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	9,109	6,188	5,155	6,408	5,621	6,393	7,759	8,523	55,156
CDER	20	54	44	119	207	283	411	501	1,639
CBER	6	9	19	36	56	49	61	58	294
CDRH	153	312	272	198	95	237	172	136	1,575
CVM
OC
Totals	9,288	6,563	5,490	6,761	5,979	6,962	8,403	9,218	58,664

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