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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…
- Australian regulator TGA opens consultation on automated decision making for listed medicine variationsThe Therapeutic Goods Administration has launched a public consultation to gather input on proposed changes that would enable automated decision making for variation applications of listed medicine…