Assessment report published [GxP / QC / QA]

posted by Ohlbe – France, 2024-06-05 14:45 (13 d 23:09 ago) – Posting: # 24022
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Dear Helmut,

❝ Only one sponsor succeeded to get off the list. No idea how they did it.


The assessment report has now been published. Mystery solved. The MAH had submitted the same response as other MAH for the same product: Synapse only did a fed study, a fasting study was done elsewhere and is sufficient according to EMA's product-specific guideline. Due to a "technical issue" this response had not been considered during the initial assessment.

Regards
Ohlbe

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