Two widely criticized requirements as well as the remainder of the Food and Drug Administration’s “additional conditions for nonprescription use” final rule are being reviewed by the agency as the Trump administration delays the rule’s effective date by nearly two months.
ACNU Rule Gets Review As Trump’s ‘Regulatory Freeze’ Delays Effective Date Two Months
Critics of requirements that sponsors first demonstrate conventional labeling wouldn’t support an OTC switch before submitting proposals for ACNU switches and for simultaneous availability of Rx formulations of approved ACNU switches likely look to delay as chance to convince the agency to strike one or both components of the final rule.
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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.
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