The paper replaces a draft version issued in January 2020 with only some minor revisions. (RELATED: EMA Consults on GMP Reflection Paper, Regulatory Focus, 22 January 2020). The paper covers the ...
The European Medicines Agency (EMA) has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative ...
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