The Food and Drug Administration (FDA) asked for rare disease stakeholders, including individuals and families affected by rare disease(s), pharmaceutical companies, trade associations, and other federal agencies and regulators, to weigh in on a proposed clinical trial rare disease network. The aim for the network is to move towards a harmonized standard and assessment in the clinical trial process, to help expedite and improve the process for treatments or drug therapies for rare diseases to reach the market faster, with safety still as a top priority. The National Organization for Rare Diseases (NORD), stated that the program has “the potential to revolutionize rare disease drug development and review.”
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