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US | EN
Cell and gene therapies (CGTs) offer an innovative approach to treating certain conditions, but the regulatory landscapes for these advanced therapies differ significantly between the US and the EU. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have distinct approaches to drug development and review processes. Understanding these differences is crucial for navigating the complex regulatory environments and successfully bringing CGTs to market in both regions.
In our eBook, we explore the top five areas where these processes differ, providing insights for companies seeking market access in the US and the EU. The eBook also discusses the potential for regulatory convergence to enhance drug development across borders. Until such harmonization occurs, partnering with an industry-leading CDMO like Thermo Fisher Scientific, which has extensive experience navigating regulatory standards in both regions, can be invaluable. To learn more, download our eBook.
