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| HHS/FDA | RIN: 0910-AF14 | Publication ID: Spring 2008 |
| Title: Expanded Access to Investigational Drugs for Treatment Use | |
| Abstract: The Food and Drug Administration proposed in the Federal Register of December 14, 2006 (75 FR 75147), to amend the regulations governing investigational new drugs (IND) to describe the ways patients may obtain investigational drugs for treatment use under expanded access programs. Such use of investigational drugs would be available to: (1) Individual patients, including in emergencies; (2) intermediate size patient populations; and (3) larger populations under a treatment protocol or treatment IND. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 312.42; 21 CFR 312.300; 21 CFR 312.305; 21 CFR 312.310; 21 CFR 312.315; 21 CFR 312.320 | |
| Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
| Small Entities Affected: Organizations | Federalism: No |
| Included in the Regulatory Plan: Yes | |
| RIN Data Printed in the FR: Yes | |
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Agency Contact: Christine F. Rogers Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 6316, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301-847-8440 Email: christine.rogers@fda.hhs.gov |
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