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    FDA authorizes new device to help diagnose pediatric autism

    The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years.   The device was developed by Cognoa, a company based in Palo Alto, CA, that develops diagnostic devices for the pediatric population. The company submitted its application, for the de novo pathway for new types of low-to-moderate-risk devices in September 2020.   ...
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    FDA to Discuss Autism and Available Treatments in May

    An upcoming public meeting is intended to allow the US Food and Drug Administration (FDA) to obtain patient perspectives on the impact of autism on daily life, as well as views on treatment approaches. Background As part of commitments tied to the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), under Title I of the Food and Drug Administration Safety and Innovation Act , FDA has selected autism as the focus of a public meeting on 4 May 2017, fr...
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    EMA Seeks Input on First Guidance for Autism Treatments

    The European Medicines Agency (EMA) on Friday released its first guidance to help drugmakers develop therapies to treat autism spectrum disorder (ASD). The draft guideline seeks to provide advice on four critical areas of clinical development: diagnosis and inclusion criteria for patient selection in clinical trials, methods for assessing efficacy, clinical trial design and measuring drug safety. Currently, ASD treatment focuses primarily on behavioral therapy and speci...
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    European Regulatory Roundup: EMA Calls for More Research Into Autism Diagnostic Tools (10 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Review Calls on Regulators to Limit Levels of Antimicrobials in Production Plant Wastewater A review commissioned by the British government has called for regulators to limit the levels of antimicrobials in manufacturing plant wastewater. By capping the concentration of antimicrobials in wastewater, regulators may contribute to a stemming of the rise of drug-resistant s...