C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 601—LICENSING › Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses

21 C.F.R. § 601.40

Scope

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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).

Notes of Decisions
Cited in 1 case, 1999–1999 · leading case: Harrison v. Blue Cross Blue Shield (D.N.H. 1999).
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Harrison v. Blue Cross Blue Shield (D.N.H. 1999). “21 C.F.R. § 601.40 (1998) ("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 benefits to patients over existing treatments.”
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