The first pressure test for whether the US Food and Drug Administration’s overhaul to its OTC monograph program made it more efficient could be teed up with the agency’s proposed order to remove oral phenylephrine as a nasal decongestant ingredient.
US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process
Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.
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