Regulation Text
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).
Authority
21 U.S.C. 321,331,351,352,353,355,355a,355f,356,356a,356b,356c,356e,360cc,360ddd,360ddd-1,371,374,379e,379k-1.
Related Guidelines (6)
Product Development Under the Animal Rule (Status: Final)
→Special Protocol Assessment Guidance for Industry (Status: Final)
→Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment (Status: Draft)
→Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry: Draft Guidance for Industry (Status: Draft)
→Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (Status: Draft)
→Development of Non-Opioid Analgesics for Chronic Pain: Draft Guidance for Industry (Status: Draft)
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