![Board on Health Sciences Policy & Committee on Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union: Regulatory Processes for Rare Disease Drugs in the United States and Europea Copertina di Board on Health Sciences Policy & Committee on Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union: Regulatory Processes for Rare Disease Drugs in the United States and Europea](https://static.worldofdigitals.com/info_webp/580/9780309726580.webp)
Rare diseases, such as sickle cell disease and thalassemia, affect up to 30 million people in the United States and at least 300 million across the globe. Congress called on the U.S. Food and Drug Administration (FDA) to sponsor a National Academies study on processes for evaluating the safety and efficacy of drugs for rare diseases or conditions in the United States and the European Union. The resulting report provides recommendations for enhancing and promoting rare disease drug development by improving engagement with people affected by a rare disease, advancing regulatory science, and fostering collaboration between FDA and the European Medicines Agency.
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Lingua Inglese ● Formato EPUB ● Pagine 386 ● ISBN 9780309726580 ● Editore Carolyn K. Shore & Carson W. Smith ● Casa editrice National Academies Press ● Pubblicato 2024 ● Scaricabile 3 volte ● Moneta EUR ● ID 10044764 ● Protezione dalla copia Adobe DRM
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