2020 In Review: Highlights, Lowlights and Forgotten Milestones
Our interactive timeline tracks the rush of activities that led to the authorization of the first coronavirus vaccines and includes other major non-COVID developments that provide a full picture of this extraordinary year.
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With Intarcia's request, the rarely used mechanism could now produce two hearing this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.
Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.
Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.