Amanda Sicard Amanda Sicard

Why the US Leaving the World Health Organization is Short-Sighted

On 22 January 2026, the United States announced that it was formally withdrawing from the World Health Organization. Public health experts, analysts, scientists, and those of us who work in the field find this a dangerous decision that will jeopardize national and global security and is scientifically reckless.

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Amanda Sicard Amanda Sicard

Are Your Quality Systems Inspection Ready?

​An excellent and sustainable quality management system is the heartbeat of pharmaceutical safety and long-term compliance. This week in the Guardrail, we examine the shift from reactive audit preparation to a proactive culture of regulatory excellence.

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FDA Regulations Amanda Sicard FDA Regulations Amanda Sicard

Navigating Intense Drug Market Pressures

Today’s global drug market faces more pressure than ever before. Pharmaceutical companies deal with higher development costs, tougher regulations, stricter pricing, and more competition from generics and biosimilars. Meanwhile, patients, payers, and governments want quicker access to safe and effective treatments. These factors are changing how companies plan, develop, launch, and manage products over time.

To succeed, companies need to know what causes market pressure and how it shapes their decisions. They also have to adjust their strategies while keeping quality, safety, and compliance intact.

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