Submission Statistics

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Submission Statistics Archives

FDA ESG 2014-2024 Total Submission Statistics

	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024	Totals
AERS	1,026,314	1,321,114	1,533,378	1,698,094	2,118,827	2,160,020	2,224,503	2,287,430	2,372,414	2,329,606	2,217,583	21,289,283
CDER	139,322	159,515	165,932	189,141	221,471	236,584	259,284	283,135	286,917	298,049	319,521	2,558,871
CBER	9,506	11,294	20,278	52,197	56,044	70,900	74,545	716,525	646,370	194,261	148,184	2,000,104
CDRH	812,443	1,478,524	2,032,767	1,921,871	2,247,286	2,774,852	2,960,441	3,774,725	4,851,638	4,110,044	4,631,821	31,596,412
CVM	44,607	52,601	64,197	70,436	70,682	74,750	86,437	88,216	85,983	106,500	135,589	879,998
OC	68,171	60,943	56,517	71,545	77,353	76,549	73,369	58,843	61,314	56,060	58,265	718,929
CTP	324	734	612	23,984	19,142	3,698	10,563	5,096	4,638	1,763	3,171	73,725
ACA	195	212	228	218	236	271	288	233	295	322	261	2,759
GDUFA	3,547	2,906	1,644	1,600	1,455	1,305	1,249	839	966	1,134	1,005	17,650
CFSAN *	2,756	3,761	3,619	2,661	2,421	2,261	2,160	2,540	2,240	2,673	2,184	29,276
HFP *											2,924	2,924
HC	5,835	9,366	16,497	23,595	26,927	27,302	35,167	40,392	37,634	38,039	37,074	297,828
ORA *								57	58	27	14	156
OII *									0	0	0	0
Totals	2,113,020	3,100,970	3,895,669	4,055,342	4,841,844	5,428,492	5,728,006	7,258,031	8,350,467	7,138,478	7,557,596	59,467,915

Note: * On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency.  

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FDA ESG 2024 Monthly Submission Statistics

	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	185,398	193,376	173,136	183,932	186,020	168,632	207,012	177,222	181,400	214,109	172,058	175,288	2,217,583
CDER	25,264	26,288	26,134	27,123	27,598	25,622	28,325	26,172	27,271	28,620	25,910	25,194	319,521
CBER	18,741	14,082	12,109	11,312	21,659	8,551	10,595	10,089	9,247	12,304	10,420	9,075	148,184
CDRH	340,896	363,556	317,844	348,358	432,142	381,393	426,715	447,484	396,950	394,566	409,979	371,938	4,631,821
CVM	12,085	10,607	10,779	11,937	12,466	11,533	11,903	10,430	12,407	11,608	9,888	9,946	135,589
OC	6,117	3,209	3,433	4,092	4,674	3,790	4,439	4,128	3,765	6,810	5,503	8,305	58,265
CTP	194	157	322	423	227	281	318	282	225	217	216	309	3,171
ACA	5	38	142	19	11	4	5	33	1	1	0	2	261
GDUFA	4	4	4	50	524	60	263	16	17	45	10	8	1,005
CFSAN	275	238	219	204	285	236	258	207	262				2,184
HFP										1,020	1,031	873	2,924
HC	3,111	3,060	2,937	3,187	3,246	2,938	3,437	2,856	2,871	3,237	3,108	3,086	37,074
ORA	2	0	10	1	0	0	1	0	0				14
OII										0	0	0	0
Totals	592,092	614,615	547,069	590,638	688,852	603,040	693,271	678,919	634,416	672,537	638,123	604,024	7,557,596

 

 

FDA ESG 2024 Monthly Acknowledgement Statistics

	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	185,398	193,376	173,136	183,932	186,020	168,632	207,012	177,222	181,400	214,109	172,058	175,288	2,217,583
CDER	50,528	52,576	52,268	54,246	55,196	51,244	56,650	52,344	54,542	57,240	51,820	50,388	639,042
CBER	37,482	28,164	24,218	22,624	43,318	17,102	21,190	20,178	18,494	24,608	20,840	18,150	296,368
CDRH	1,022,688	1,090,668	953,532	1,045,074	1,296,426	1,144,179	1,280,145	1,342,452	1,190,850	1,183,698	1,229,937	1,115,814	13,895,463
CVM	24,170	21,214	21,558	23,874	24,932	23,066	23,806	20,860	24,814	23,216	19,776	19,892	271,178
OC	12,234	6,418	6,866	8,184	9,348	7,580	8,878	8,256	7,530	13,620	11,006	16,610	116,530
CTP	388	314	644	846	454	562	636	564	450	434	432	618	6,342
ACA	10	76	284	38	22	8	10	66	2	2	0	4	522
GDUFA	8	8	8	100	1,048	120	526	32	34	90	20	16	2,010
CFSAN	275	238	219	204	285	236	258	207	262				2,184
HFP										1,020	1,031	873	2,924
HC	6,222	6,120	5,874	6,374	6,492	5,876	6,874	5,712	5,742	6,474	6,216	6,172	74,148
ORA	2	0	10	1	0	0	1	0	0				14
OII										0	0	0	0
Totals	1,339,405	1,399,172	1,238,617	1,345,497	1,623,541	1,418,605	1,605,986	1,627,893	1,484,120	1,524,511	1,513,136	1,403,825	17,524,308

 

FDA ESG 2024 Monthly Total Traffic Statistics

	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	370,796	386,752	346,272	367,864	372,040	337,264	414,024	354,444	362,800	428,218	344,116	350,576	4,435,166
CDER	75,792	78,864	78,402	81,369	82,794	76,866	84,975	78,516	81,813	85,860	77,730	75,582	958,563
CBER	56,223	42,246	36,327	33,936	64,977	25,653	31,785	30,267	27,741	36,912	31,260	27,225	444,552
CDRH	1,363,584	1,454,224	1,271,376	1,393,432	1,728,568	1,525,572	1,706,860	1,789,936	1,587,800	1,578,264	1,639,916	1,487,752	18,527,284
CVM	36,255	31,821	32,337	35,811	37,398	34,599	35,709	31,290	37,221	34,824	29,664	29,838	406,767
OC	18,351	9,627	10,299	12,276	14,022	11,370	13,317	12,384	11,295	20,430	16,509	24,915	174,795
CTP	582	471	966	1,269	681	843	954	846	675	651	648	927	9,513
ACA	15	114	426	57	33	12	15	99	3	3	0	6	783
GDUFA	12	12	12	150	1,572	180	789	48	51	135	30	24	3,015
CFSAN	550	476	438	408	570	472	516	414	524				4,368
HFP										2,040	2,062	1,746	5,848
HC	9,333	9,180	8,811	9,561	9,738	8,814	10,311	8,568	8,613	9,711	9,324	9,258	111,222
ORA	4	0	20	2	0	0	2	0	0				28
OII										0	0	0	0
Totals	1,931,497	2,013,787	1,785,686	1,936,135	2,312,393	2,021,645	2,299,257	2,306,812	2,118,536	2,197,048	2,151,259	2,007,849	25,081,904

 

FDA ESG 2023 Monthly Submission Statistics

	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	201,379	188,228	202,526	181,068	198,262	198,480	188,832	203,874	186,292	199,836	200,539	180,290	2,329,606
CDER	21,089	22,110	27,118	23,105	25,884	25,716	23,640	27,030	24,609	26,684	26,235	24,829	298,049
CBER	20,825	17,530	25,459	15,241	16,684	14,248	13,085	12,829	11,348	18,519	16,274	12,219	194,261
CDRH	318,486	308,034	376,811	365,283	319,972	342,198	397,276	369,797	312,375	333,257	369,404	297,151	4,110,044
CVM	8,401	6,596	8,161	7,699	8,789	8,519	9,739	11,089	8,449	8,786	9,480	10,792	106,500
OC	5,830	4,472	4,279	3,012	3,254	3,603	3,122	3,545	3,474	6,799	6,536	8,134	56,060
CTP	118	194	182	105	122	141	139	150	102	148	157	205	1,763
ACA	3	25	247	28	0	3	1	1	5	0	1	8	322
GDUFA	11	19	35	11	556	132	31	21	263	19	19	17	1,134
CFSAN	137	173	336	180	234	205	252	240	186	212	299	219	2,673
HC	2,853	2,977	3,480	2,844	3,442	3,247	3,281	3,285	2,971	3,290	3,433	2,936	38,039
ORA	1	7	5	1	0	2	4	0	1	0	6	0	27
Totals	579,133	550,365	648,639	598,577	577,199	596,494	639,402	631,861	550,075	597,550	632,383	536,800	7,138,478

 

FDA ESG 2023 Monthly Acknowledgement Statistics

	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	201,379	188,228	202,526	181,068	198,262	198,480	188,832	203,874	186,292	199,836	200,539	180,290	2,329,606
CDER	42,178	44,220	54,236	46,210	51,768	51,432	47,280	54,060	49,218	53,368	52,470	49,658	596,098
CBER	41,650	35,060	50,918	30,482	33,368	28,496	26,170	25,658	22,696	37,038	32,548	24,438	388,522
CDRH	955,458	924,102	1,130,433	1,095,849	959,916	1,026,594	1,191,828	1,109,391	937,125	999,771	1,108,212	891,453	12,330,132
CVM	16,802	13,192	16,322	15,398	17,578	17,038	19,478	22,178	16,898	17,572	18,960	21,584	213,000
OC	11,660	8,944	8,558	6,024	6,508	7,206	6,244	7,090	6,948	13,598	13,072	16,268	112,120
CTP	236	388	364	210	244	282	278	300	204	296	314	410	3,526
ACA	6	50	494	56	0	6	2	2	10	0	2	16	644
GDUFA	22	38	70	22	1,112	264	62	42	526	38	38	34	2,268
CFSAN	137	173	336	180	234	205	252	240	186	212	299	219	2,673
HC	5,706	5,954	6,960	5,688	6,884	6,494	6,562	6,570	5,942	6,580	6,866	5,872	76,078
ORA	1	7	5	1	0	2	4	0	1	0	6	0	27
Totals	1,275,235	1,220,356	1,471,222	1,381,188	1,275,874	1,336,499	1,486,992	1,429,405	1,226,046	1,328,309	1,433,326	1,190,242	16,054,694

 

FDA ESG 2023 Monthly Total Traffic Statistics

	Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sept	Oct	Nov	Dec	Totals
AERS	402,758	376,456	405,052	362,136	396,524	396,960	377,664	407,748	372,584	399,672	401,078	360,580	4,659,212
CDER	63,267	66,330	81,354	69,315	77,652	77,148	70,920	81,090	73,827	80,052	78,705	74,487	894,147
CBER	62,475	52,590	76,377	45,723	50,052	42,744	39,255	38,487	34,044	55,557	48,822	36,657	582,783
CDRH	1,273,944	1,232,136	1,507,244	1,461,132	1,279,888	1,368,792	1,589,104	1,479,188	1,249,500	1,333,028	1,477,616	1,188,604	16,440,176
CVM	25,203	19,788	24,483	23,097	26,367	25,557	29,217	33,267	25,347	26,358	28,440	32,376	319,500
OC	17,490	13,416	12,837	9,036	9,762	10,809	9,366	10,635	10,422	20,397	19,608	24,402	168,180
CTP	354	582	546	315	366	423	417	450	306	444	471	615	5,289
ACA	9	75	741	84	0	9	3	3	15	0	3	24	966
GDUFA	33	57	105	33	1,668	396	93	63	789	57	57	51	3,402
CFSAN	274	346	672	360	468	410	504	480	372	424	598	438	5,346
HC	8,559	8,931	10,440	8,532	10,326	9,741	9,843	9,855	8,913	9,870	10,299	8,808	114,117
ORA	2	14	10	2	0	4	8	0	2	0	12	0	54
Totals	1,854,368	1,770,721	2,119,861	1,979,765	1,853,073	1,932,993	2,126,394	2,061,266	1,776,121	1,925,859	2,065,709	1,727,042	23,193,172