No ACNU Yet; Effective Date Delayed Again
FDA Law Blog: Biosimilars
MARCH 23, 2025
By Deborah L. Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. We wrote about the December 26, 2024 publication of the final rule (89 FR 105288) here. Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025.
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