European Medicines Agency Guideline On The Clinical Development Of Medicinal Products For The Treatment Of Autism Spectrum Disorder

On March 4, 2016, the European Medicines Agency (EMA) released its first guidance on developing medications to treat autism spectrum disorder (ASD), and the key priority is that the medication must demonstrate efficacy on one or more core ASD symptoms, and should show both short- and long-term efficacy and safety. Currently the EMA has approved no medications for use as treatment for autism, although in the United States, the Food and Drug Administration (FDA) has approved two antipsychotics to treat irritability. The guideline provides advice on diagnosis and inclusion criteria for the selection of patients, methods for assessment of . . .