Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms
Agency IQ
OCTOBER 6, 2023
For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. Earlier this year, the FDA reported that, for FY 2021, 31% of all required post-marketing studies had not yet been completed and were off-schedule for future completion.
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