FDA Globalization Capacity, Shortage Monitoring Remain Concerns, GAO Says

In updated high-risk report, GAO says resources are an issue for FDA’s globalization plans and the agency should better manage its drug shortage data.

GAO continues to question FDA’s ability to adequately conduct risk-based inspections of foreign drug manufacturers, even though the agency has boosted the total in recent years.

In a Feb. 11 update of its “High-Risk Series,” which outlines areas where problems may lead to waste, fraud and mismanagement, the Government Accountability Office continued its calls...

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HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
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By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

US FDA’s Familiar Drug Pricing To-Do List

 

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

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