Regulatory Processes for Rare Disease Drugs in the United States and European Union
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Informação do Produto
| ISBN | 9780309726559 |
|---|---|
| Autores | Board on Health Sciences Policy, Committee on Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions, Engineering, and Medicine National Academies of Sciences, Health and Medicine Division |
| Editora | National Academies Press |
| Formato | Capa mole |
| Número de páginas | 363 |
| Peso (kg) | 0,628 |
| Data de Publicação | 30/10/2024 |
| Preço (iva excl.) | € 40,47 |
| Imposto | € 2,43 |
| Preço (iva inc.) | € 42,90 |
| Disponibilidade | 1 unidade em armazém externo |
Descrição do Produto
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.