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- FDA finalizes guidance on therapeutic equivalence evaluations for ANDAsThe U.S. Food and Drug Administration has issued final guidance describing its approach to therapeutic equivalence (TE) evaluations and the assignment of TE codes for abbreviated new drug applicati…
- Early Alert: Nitric Oxide Delivery System Issue from NOxBOXThe NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy