• FY 2014 -2018 CDER, CBER and CDRH Expanded Access (Compassionate Use) Submission Data Archive

CBER and CDER Data through 2014

CBER and CDER Tables

• CBER and CDER Expanded Access INDs
• CBER and CDER Expanded Access Protocols
• CDER and CBER Totals for Expanded Access

CBER and CDER Expanded Access INDs

Expanded Access INDs		Individual (Single) Patient Non-Emergency IND		Individual (Single) Patient Emergency IND		Intermediate Size IND		Treatment IND
		received	allowed to proceed	received	allowed to proceed	received	allowed to proceed	received	allowed to proceed
FY 2014	CDER	696	692	1069	1066	52	50	0	0
	CBER	22	19	45	44	1	1	1	1
FY 2013	CDER	550	550	315	313	28	27	0	0
	CBER	31	112	112	10	8	0	0
FY 2012	CDER	289	287	14	14	0	0
	CBER	47	39	36	35	1	1	2	2
10/2010 to 10/2011***	CDER	652	652	443	442	0	0	1	1
	CBER	22	18	24	24	4	4	1	1
10/13/2009 to 10/12/2010***	CDER	484	484	516	500	2	2	0	0
	CBER	17	14	24	24	1	1	0	0

*** These reporting periods cover a one year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

CBER and CDER Expanded Access Protocols

Expanded Access INDs		Individual (Single) Patient Non-Emergency IND		Individual (Single) Patient Emergency IND		Intermediate Size IND		Treatment IND
		received	allowed to proceed	received	allowed to proceed	received	allowed to proceed	received	allowed to proceed
FY 2014	CDER	35	35	9	9	9	9	12	12
	CBER	33	32	22	22	5	5	2	2
FY 2013	CDER	62	62	2	2	8	8	12	12
	CBER	56	56	14	14	7	5	0	0
FY 2012	CDER	121	121	0	0	8	8	10	10
	CBER	49	47	19	19	3	2	0	0
10/2010 to 10/2011***	CDER	89	89	3	3	1	1	11	11
	CBER	36	36	6	6	4	4	1	1
10/13/2009 to 10/12/2010***	CDER	16	16	0	0	5	5	7	7
	CBER	31	30	4	4	1	1	0	0

*** These reporting periods cover a one year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

CDER and CBER Totals for Expanded Access^*

Totals for Expanded Access		Total Number of Expanded Access INDs and Protocols received	Total Number of Expanded Access INDs and Protocols allowed to proceed
FY 2017	CDER	1637	1632
	CBER	205	199
FY 2016	CDER	1545	1536
	CBER	203	196
FY 2015	CDER	1262	1256
	CBER	168	160
FY 2014	CDER	1881	1873
	CBER	131	126
FY 2013	CDER	977	974
	CBER	236	226
FY 2012	CDER	940	936
	CBER	157	145
10/2010 to 10/2011***	CDER	1200	1199
	CBER	100	93
10/13/2009 to 10/12/2010***	CDER	1030	1014
	CBER	78	74

* These data ceased being compiled as of FY 2017.

*** These reporting periods cover a one year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.