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HHS/FDA | RIN: 0910-AF13 | Publication ID: Fall 2009 |
Title: Charging for Investigational Drugs Under an Investigational New Drug Application | |
Abstract: On August 13, 2009 (74 FR 40872), FDA published a final rule amending FDA's investigational new drug regulations concerning charging for investigational drugs. The rule clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of treatment uses described in the Agency's rule on expanded access to investigational drugs for treatment use, and clarifies what costs can be recovered for an investigational drug. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 312.7 and 312.8 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 356 21 USC 371 21 USC 381 to 383 21 USC 393 42 USC 262 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Colleen Locicero Associate Director for Regulatory Affairs Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Building 22, Room 4200, Silver Spring, MD 20993-0002 Phone:301 796-2270 Fax:301 796-9840 Email: colleen.locicero@fda.hhs.gov |