Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes
FDA Law Blog: Biosimilars
JULY 29, 2024
In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters.
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