Home » EMA Posts Biosimilars Q&A to Prep Drugmakers for Presubmission Pow Wows
EMA Posts Biosimilars Q&A to Prep Drugmakers for Presubmission Pow Wows
April 12, 2012
The European Medicines Agency (EMA) has published question-and-answer guidance on marketing applications for biosimilars, providing advice on a number of pre-submission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing.
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