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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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Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

US FDA Cancels Panel Review Of Two ‘Delinquent’ Cancer Drug Accelerated Approvals

Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.

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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