Drifting too far from shore: paternal valproate statement by the European Medicines Agency (EMA)

<p dir="ltr"><b>Summary</b></p><ul><li>Transparency is pivotal to trust between clinicians, academics, and regulatory authorities.</li><li>Data and methodology supporting regulatory decisions must be made publicly available.</li><li>Measurements of neurodevelopmental outcomes are complex and controversial.</li><li>Data on paternal exposure to valproate are insufficient to warrant far-reaching precautions.</li><li>Regulatory, academic, and clinical collaboration is essential to communicate risk.</li></ul><p></p>