Drifting too far from shore: paternal valproate statement by the European Medicines Agency (EMA)
Year: 2025
Type: article
Abstract: Summary Transparency is pivotal to trust between clinicians, academics, and regulatory authorities. Data and methodology supporting regulatory decisions must be made publicly available. Measurements of neurodevelopmental outcomes are complex and controversial. Data on paternal exposure to valproate are insufficient to warrant far-reaching precautions. Regulatory, academic, and clinical collaboration is essential to communicate risk.
Source: Figshare
Authors: Per Damkier (3443144), Svetlana Shechtman (20441242), Orna Diav-Citrin (20441245), Alice Panchaud (2575918), Corinna Weber-Schoendorfer (20441249), Kenneth Hodson (20441257), Brian Cleary (7899086)
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7075601808
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