REGULATORY PROCESSES FOR RARE DISEASE DRUGS IN THE UNITED STATES AND EUROPEAN UNION Impresión bajo demanda

REGULATORY PROCESSES FOR RARE DISEASE DRUGS IN THE UNITED STATES AND EUROPEAN UNION

Código de artículo:
4396094498
ISBN:
9780309726559
Páginas:
386
Tipo de libro:
Impresión bajo demanda
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Impresión Bajo Demanda.


Tiempo de despacho de pedidos es de 15 a 20 días hábiles, una vez confirmado el pago del pedido. 

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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