Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Takeda’s Maribavir Post-Transplant CMV Indication Should Not Be Limited By Resistance, US Panel Says
Advisory committee unanimously endorses novel antiviral for treatment of post-transplant patients with refractory/resistant cytomegalovirus infection, and in the process rejects US FDA’s proposal to distinguish target population based upon genetic resistance.
The US FDA has designated a recall of Haimen Shengbang Laboratory Equipment Co. viral transport media containers as class I, the agency’s most serious designation.
The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.