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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…
- Health Secretary Kennedy criticizes CDC vaccine classification scheme and shared decision-making categoryRobert F. Kennedy Jr., serving as Health Secretary, has raised concerns about how the CDC categorizes vaccine recommendations. The CDC uses three categories: routine recommendations for universal…