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Regulatory Processes for Rare Disease Drugs in the United States and European Union
Engelsk
Bogcover for Regulatory Processes for Rare Disease Drugs in the United States and European Union af , 9780309726559
Specifikationer
Sprog:
Engelsk
Sider:
386
ISBN-13:
9780309726559
Indbinding:
Paperback
ISBN-10:
0309726557
Udg. Dato:
30 nov 2024
Størrelse i cm:
22,9 x 15,2 x 2,5
Oplagsdato:
30 nov 2024

Regulatory Processes for Rare Disease Drugs in the United States and European Union

Engelsk
Paperback 2024
Format:

Bog beskrivelse

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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Specifikationer
Sprog:
Engelsk
Sider:
386
ISBN-13:
9780309726559
Indbinding:
Paperback
ISBN-10:
0309726557
Udg. Dato:
30 nov 2024
Størrelse i cm:
22,9 x 15,2 x 2,5
Oplagsdato:
30 nov 2024
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