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US FDA’s 22nd Patient-Focused Drug Development meeting focused on the challenging disease of autism. It also showed how far FDA has come in embracing the patient-input process over the past five years.
US agency may face challenge of keeping May 4 meeting on patient-focused drug development focused on autism disease burden and current therapeutic approaches rather than vaccine safety.
This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.
While short-term efficacy in core symptoms should be demonstrated first, EMA draft drug development guidance also calls for a showing of positive effect on global function and maintenance of long-term efficacy.