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. § 601.42

Approval with restrictions to assure safe use

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(a) If FDA concludes that a biological product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the biological product, such as:

(1) Distribution restricted to certain facilities or physicians with special training or experience; or

(2) Distribution conditioned on the performance of specified medical procedures.

(b) The limitations imposed will be commensurate with the specific safety concerns presented by the biological product.

Notes of Decisions
Cited in 1 case, 2016–2016 · leading case: Christison v. Biogen Idec Inc., 199 F. Supp. 3d 1315 (D. Utah 2016).
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Christison v. Biogen Idec Inc., 199 F. Supp. 3d 1315 (D. Utah 2016). “FDA re-approved Tysabri in June 2006 “under the provisions of 21 CFR 601.42 (Subpart E) ... for use as recommended in the agreed upon labeling text, required patient labeling, and the components of the TOUCH™ Risk Minimization Action Plan (RiskMAP).”
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