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HHS/FDA | RIN: 0910-AF14 | Publication ID: Fall 2003 |
Title: ●Treatment Use of Investigational Drugs | |
Abstract: The proposed rule would amend FDA regulations governing investigational new drug applications (INDs) to describe the way patients may obtain investigational drugs for treatment use. Treatment use of investigational drugs would be available to: (1) individual patients, including in emergencies; (2) intermediate size patient; and (3) larger populations under a treatment protocol or IND. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: Undetermined |
CFR Citation: 21 CFR 312.42 21 CFR 312.400 21 CFR 312.405 21 CFR 312.410 21 CFR 312.415 21 CFR 312.420 21 CFR 312.425 21 CFR 312.430 21 CFR 312.435 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 353 21 USC 355 21 USC 371 42 USC 262 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Small Entities Affected: Businesses | Federalism: Undetermined |
Included in the Regulatory Plan: No | |
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 |