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THE GLP-1 FILES, PART 1: Digging Holes to Fill Them?

There is a strange paradox taking shape in aesthetic medicine, predicated in large part by GLP-1 therapies for weight loss. No longer a niche treatment,...

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RWE: From Regulatory Footnote to the Future of Medical Affairs, Part 2.

A Higher Bar, A Wider Net: What ICH M14 and the New RWE Standards Mean for Medical Affairs In Part 1 of this series, we...

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RWE: From Regulatory Footnote to the Future of Medical Affairs, Part 1.

In the fall of 1960, a newly hired pharmacologist named Frances Kelsey received her first assignment at the FDA: review a drug called Kevadon [1]....

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What Canadians Don’t See: Inside the Rules Governing Pharmaceutical Advertising

Do you ever wonder why pharmaceutical ads on Canadian TV stations are so radically different from US ads? That’s because Canada has distinctly different regulations,...

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Clinical Guideline Development (Part 5): Why Guidelines Fail – The Structural Forces That Undermine Credibility, Stall Timelines, and Compromise Independence

  Many guideline failures are not failures of evidence alone, they are failures of process. Economic constraints, logistical complexity, and political realities exert a profound...

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