US FDA’s Coronavirus Workload Shifting Beyond Idea Stage
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.
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Data suggests fewer approvals and new product ideas, as the business case for new generic and brand treatments seems to be tougher to make now than at other times during the pandemic.
Biosimilars continue their erratic behavior, with the low numbers driving big swings.
In FY '21 third quarter, on-time decision rate improved for generics and biosimilars, but dropped again for new drug applications.