Lexology July 15, 2022
Welcome to the latest issue of FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal and regulatory world.
FDA announces new action plan for rare neurodegenerative diseases. On June 23, the FDA announced its new Action Plan for Rare Neurodegenerative Diseases Including Amyotrophic Lateral Sclerosis (ALS). This, the agency said, is a five-year strategy for improving and extending the lives of people living with rare neurodegenerative diseases by advancing the development of safe and effective medical products and facilitating patients’ access to novel treatments. FDA Commissioner Robert Califf said, “The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent...
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