Regulation Text
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).
Authority
15 U.S.C. 1451-1561;21 U.S.C. 321,351,352,353,355,356b,360,360c-360f,360h-360j,371,374,379e,381;42 U.S.C. 216,241,262,263,264; sec 122,Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e),Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N,Pub. L. 116-94, 133 Stat. 3127.
Related Guidelines (5)
Systemic Lupus Erythematosus --Developing Medical Products for Treatment (Status: Final)
→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 and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry (Status: Final)
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