Marketing authorization applications for psychedelics must align with the regulatory requirements and evidentiary standards required for the approval of all medicinal products in the European Union. While medicine regulators recognize the therapeutic potential of psychedelics, their characteristics present methodological challenges that complicate the design and interpretation of pivotal trials...
In "Prescription for Love: An Experimental Investigation of Laypeople's Relative Moral Disapproval of Love Drugs," Lantian, Boudesseul, and Cova (2024) explore the moral implications of hypothetical romantic love-enhancing biotechnological interventions. Their study reveals "love drugs" (LDs) are viewed as less acceptable than psychological therapy due to the perceived inauthenticity of the...
There is a growing body of clinical research on the therapeutic potential of psychedelics for the treatment of mental health disorders, notably depression. Accordingly, the new revision of the European Medicines Agency guideline on the clinical investigation of products for depression will incorporate a section covering specific regulatory recommendations for the design of studies with...