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doi: 10.1111/j.1468-1331.2004.00813.x, PMID: [DOI] [PubMed] [Google Scholar] 35.Nambiar N, Aiyappa C, Srinivasa R

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In April 2026, the FDA moved a group of them out of Category 2 toward advisory-committee review, and despite favorable voting, the formal rulemaking is still pending