Regulatory Processes for Rare Disease Drugs in the United States and European Union: Flexibilities and Collaborative Opportunities - Couverture souple

National Academies Of Sciences, Engineering, And Medicine; Health And Medicine Division; 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

Couverture souple

ISBN 10 : 0309726557 ISBN 13 : 9780309726559

Editeur : National Academies Press, 2024

Synopsis

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.

Détails de l'édition

• Éditeur: National Academies Press
• Date d'édition: 2024
• Langue: anglais
• ISBN 10: 0309726557
• ISBN 13: 9780309726559
• Reliure: Broché
• Nombre de pages: 386
• Éditeur: Shore Carolyn K., Worku Tequam L., Smith Carson W., Kahn Jeffrey P.
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible