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. § 601.41

Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity

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FDA may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will be subject to the requirement that the applicant study the biological product further, to verify and describe its clinical benefit, where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical benefit to ultimate outcome. Postmarketing studies would usually be studies already underway. When required to be conducted, such studies must also be adequate and well-controlled. The applicant shall carry out any such studies with due diligence.

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). · cites it 3× “The product was judged under the standards for accelerated approval provided in 21 C.F.R. § 601.41 . Id. at 19 . Because of the accelerated approval process, post-approval studies are reguired, and Genzyme Tissue Repair committed to further development and testing, "to confirm…”
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