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Longer ACNU Rule Review Gets Kennedy Signature

 
• By Malcolm Spicer

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.

(Source: Shutterstock/Citeline)
Key Takeaways
  • The first notice was signed by an acting HHS secretary, but Kennedy put pen to paper for publishing the second.
  • Kennedy’s direct signature to the notice delaying the ACNU final rule aligns with his public interest in changing the US life science landscape, including potentially substantially adjusting the FDA’s drug evaluation and approval processes.
  • FDA isn’t accepting comments on the second on its review of the rule which will allow digital channels for consumer self-selection of nonprescription drug products and simultaneous availability of Rx formulations of approved ACNU switches.

Secretary of Health and Human Services Robert F. Kennedy Jr

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