eCFR Reference Browser

---

title: "21 CFR §601.40"

source: "https://www.ecfr.gov/current/title-21/section-601.40"

title_number: "21"

volume_number: "7"

chapter_number: "Unknown"

subchapter_code: "F"

subchapter_subject: "BIOLOGICS"

part_code: "601"

part_subject: "LICENSING"

subpart_code: "E"

subpart_subject: "Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses"

section_number: "601.40"

section_subject: "Scope."

cfr_reference: "21 CFR 601.40"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 600 to 799"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

This subpart applies to certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).

§601.40 - Scope.