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The recently released approval letter sent to Lilly for the oral GLP-1 drug gives some insights into how the FDA will regulate new medicines approved via this rapid review pathway in practice

For far too long, Americans have disproportionately shouldered the burden of financing an outsized share of research and development

Heres what makes it stand out: Small doses help minimize side effects, so treatment feels comfortable from the beginning

It is important to set realistic expectations

Access, cost and insurance concerns represented another persistent theme, accounting for approximately 12% of thematic discussion

doi: Walker, E