Sue Sutter
Senior Editor
Latest From Sue Sutter
Lilly’s Kisunla: Labeling Allows For Stopping Treatment Based On Amyloid Plaque Reduction
However, the US FDA’s approval of donanemab comes with little guidance on when to stop treatment or when the anti-amyloid agent may need to be restarted in Alzheimer’s patients.
Deference No More: More Challenges Against US FDA After Supreme Court Tosses Chevron Doctrine?
The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.
Deference No More: More Suits Against US FDA Coming After High Court Tosses Chevron Doctrine?
The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.
Purdue Bankruptcy Settlement ‘Back To Square One’ After US Supreme Court Rejection
In a 5-4 decision, the high court says a Chapter 11 bankruptcy plan provision releasing the Sackler family from future liability is not allowed, a decision that could spur a bolus of personal injury trials if another reorganization plan settling thousands of claims cannot be reached.
Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.