From the magazine LSR 1/2020 | p. 5-10 The following page is 5

Bringing CAR-T to Reality

Selected Legal and Regulatory Considerations

Medicinal Products Law


This article provides insights about the unique set-up for CAR-T therapies with regard to scientific and medical characteristics, but also manufacturing, delivery, access and commercialization. However, the regulatory and legal challenges that come along with such cutting-edge technologies are significant. They mirror the frequently encountered problem that the respective regulatory frameworks lag behind the actual scientific and medical progress. Fragmented approaches pose additional hurdles for access to CAR-T therapies.

I. Introduction

In August 2017, the US Food and Drug Administration (FDA) published a press release, announcing…

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