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Code of Federal Regulations Title 21. Food and Drugs § 21.312.81 Scope

Current as of October 02, 2022 | Updated by FindLaw Staff

This section applies to new drug and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.

(a) For purposes of this section, the term “life-threatening” means:

(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted;  and

(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.

(b) For purposes of this section, the term “severely debilitating” means diseases or conditions that cause major irreversible morbidity.

(c) Sponsors are encouraged to consult with FDA on the applicability of these procedures to specific products.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.312.81 Scope - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-312-81/

Read this complete Code of Federal Regulations Title 21. Food and Drugs § 21.312.81 Scope on Westlaw

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