part_subject: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"
subpart_code: "H"
subpart_subject: "Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses"
section_number: "314.500"
section_subject: "Scope."
cfr_reference: "21 CFR 314.500"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
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"
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This subpart applies to certain new drug 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).