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Close votes, and the Committee split with FDA's own scientific staff, who had recommended against every substance on the docket

Results: Of 6768 ICH patients included in analyses, 3296 (48.7%) and 846 (12.5%) experienced mild (ASR score = 1), moderate or significant (ASR score2) ASR at baseline

We issued a comment solicitation in section III.F of the CY 2026 OPPS/ASC proposed rule to collect information on alternative and consistent payment methods that seek to reflect the underlying value of SaaS under the OPPS to consider in future rulemaking

At best, these drugs could be a waste of money