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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

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Reata’s Bardoxolone Shot Down, But US FDA Advisors Offer Suggestions For Improved Study

Advisory committee unanimously votes against bardoxolone for Alport syndrome, unconvinced drug slows progression of chronic kidney disease and concerned about safety signals suggesting it could make the disease worse. However, panel offers Reata suggestions for a better-designed trial.

UK Imposes New Limits On Deferring Registration Of Clinical Trials

The UK is changing its policy for deferring the registration of a clinical trial on grounds of commercial sensitivity, and is introducing updated guidance on the minimum information that sponsors of such studies should still make public.

EU Bans Titanium Dioxide In Supplements, Drugs Given Reprieve, For Now

Titanium dioxide is now officially banned as an ingredient in foods and dietary supplements in the European Union on safety grounds. However, manufacturers can still place products containing the chemical compound on the market for six months, and then any products still on the market can remain until their expiry date. Meanwhile, the European Commission and pharmaceutical companies have three years to find titanium dioxide alternatives for medicines, or justify why it should continue to be used.

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