Regulations.gov document

Determination of Regulatory Review Period for Purposes of Patent Extension; EPKINLY

Notice · FDA-2024-E-0194 · posted May 14, 2025

Key facts

Document ID FDA-2024-E-0194-0008
Title Determination of Regulatory Review Period for Purposes of Patent Extension; EPKINLY
Document type Notice
Subtype Determinations
Agency FDA
Docket FDA-2024-E-0194
Posted May 14, 2025
Federal Register citation 90 FR 20474
FR document number 2025-08450
Comment period opens May 14, 2025
Comments due Jul 15, 2025
Effective date May 14, 2025

At a glance

  • 1–9 Pages
  • No Open for comment
  • None Public comments on this docket

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