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This fiscal burden transcends the issues of accessibility in low-income regions, necessitating a thorough health economic assessment across various healthcare systems

Relevant to the subject, Sweden has a free prescription right which means that a prescriber can, at his or her own discretion but judging it based on scientific evidence and proven experience, circumvent, e.g., the approved indication and prescribe a drug outside of the specifications in the Summary of Product Characteristics (SmPC), i.e., off-label

Attia, M

The entire process takes place within a highly regulated and ethically controlled environment governed by international standards including GLP, GMP and Good Clinical Practice (GCP) , as well as key EMA, FDA and ICH guidelines

& Scheres, S