21 CFR 312.305 - Requirements for all expanded access uses
| Cite as | 21 CFR 312.305 |
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18 practice notes
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The Regulatory Plan, 72725-72938 [06-8765]
...Other Significant Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262 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 Deadline: None Abstract: To amend the regulations governing investigational new drugs to des......
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Introduction to Regulatory Plan and Unified Agenda of Regulatory and Deregulatory Actions
...Other Significant Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262 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 Deadline: None Abstract: The Food and Drug Administration proposed in the Federal Register o......
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Part II
...Other Significant Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262 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 Deadline: None Abstract: The Food and Drug Administration proposed in the Federal Register o......
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Part II
...Other Significant Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262 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 Deadline: None Abstract: The Food and Drug Administration proposed in the Federal Register o......
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10 firm's commentaries
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National Right To Try Legislation Passes Congress
...or treatment protocol (21 C.F.R. § 312.320), because RTT legislation focuses on individual patient access to experimental drugs. 4 21 C.F.R. § 312.305(a)(1). A serious disease or condition is one that is "associated with morbidity that has a substantial impact on day-to-day functioning" whi......
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Right to Try Legislation: Worthwhile or Window Dressing?
...or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. 21 CFR 312.305(a)(1); 21 CFR The patient’s physician (in the case of expanded access for an individual) and the FDA determine that the potential patient bene......
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FDA Collection And Labeling Protocols For Use Of Convalescent Plasma As A Treatment For COVID-19
...plasma INDs must meet FDA's IND regulations relating to chemistry, manufacturing, and control information (see 21 CFR 312.23(a)(7) and 21 CFR 312.305(b)(2)(vi)). To meet these requirements, FDA recommends that IND applications include information that the COVID-19 plasma to be used will be ......
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FDA Issues Simpler Draft Form for Individual Patient Expanded Access Applications
...or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.” (21 CFR 312.305(a)(1).) In addition to other criteria, FDA must conclude that the patient cannot obtain the drug under another IND or protocol, and the physi......
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