Event

BioBriefing: 21st Century Cures Act - US Regulatory Impact

BioMelbourne



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About the Event

The 21st Century Cures Act (Cures Act), signed into US law on 13th December 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. The law focuses on incorporating the perspectives of patients into the development of drugs, biological products and devices in FDA’s decision-making process. Additionally, the Cures Act seeks to modernise clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products.