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e-CFR data is current as of September 24, 2020

Title 21Chapter ISubchapter FPart 601Subpart H → §601.95


Title 21: Food and Drugs
PART 601—LICENSING
Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible


§601.95   Termination of requirements.

If FDA determines after approval under this subpart that the requirements established in §§601.91(b)(2), 601.92, and 601.93 are no longer necessary for the safe and effective use of a biological product, FDA will so notify the applicant. Ordinarily, for biological products approved under §601.91, these requirements will no longer apply when FDA determines that the postmarketing study verifies and describes the biological product's clinical benefit. For biological products approved under §601.91, the restrictions would no longer apply when FDA determines that safe use of the biological product can be ensured through appropriate labeling. FDA also retains the discretion to remove specific postapproval requirements upon review of a petition submitted by the sponsor in accordance with §10.30 of this chapter.

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