ANDA Submission Boost May Dampen New Approval Record
This article was originally published in The Pink Sheet Daily
Increase in submissions could make strong approval rates tougher to maintain.
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ACIP defers vote on who should be inoculated first until it has data on a specific product, but vaccine acceptance among different groups could be weighed as factor in setting distribution priorities, committee members suggest.
The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.
Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.