Facilitating development of medicines for Autism Spectrum Disorder
The European Medicines Agency (EMA) has released a guideline on the clinical development of medicines for the treatment of Autism Spectrum Disorder (ASD) for a 6-month public consultation.
This is the first guidance document issued by the Committee for Medicinal Products for Human Use (CHMP) for developers of medicines targeting autism. It is based on recent progress in the understanding of the pathological mechanisms behind ASD. The guideline also builds on EMA scientific advice for development plans for Autism Spectrum Disorder, as well as the qualification letters of support for the selection of patients in clinical trials.
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