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HHS/FDA | RIN: 0910-AF14 | Publication ID: Spring 2006 |
Title: Expanded Access to Investigational Drugs for Treatment Use | |
Abstract: To amend the regulations governing investigational new drugs 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 IND. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed 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 |
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 | |
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 Avenue, Bldg. 51, Room 6316, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 Email: christine.rogers@fda.hhs.gov |