FDA Adds Temporary Expertise To ODAC For Filgrastim Biosimilar Meeting
This article was originally published in The Pink Sheet Daily
NIH researcher of cellular therapy manufacturing, experts in pharmacology and pharmaceutical sciences join Oncologic Drugs Advisory Committee for consideration of FDA’s first 351(k) application.
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Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application.
FDA's Peter Stein calls idea "useful"; rare disease experts would temporarily serve on standing advisory committees when needed.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.