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Quality Matters

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Quality Matters

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  • Joseph Baker
  • October 31, 2014 02:02:33 AM

A Little About Us

Official blog of US Pharmacopeia (USP), sharing unique viewpoints on the public-health impact of worldwide efforts to promote the quality and integrity of medicines, food ingredients and dietary supplements. Writers include scientists, staff, volunteer experts and representatives of USP member organizations.

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Our Legacy of Championing Access to Medicines

Our Legacy of Championing Access to Medicines Access to medicines is a complicated topic. It’s shaped by scientific factors, manufacturing processes, regulatory requirements (including expectations for quality), purchasing practices, health insurance coverage and benefits, healthcare practitioners and numerous other complex realities. What we have learned is that real progress happens when stakeholders work together to develop solutions. USP is using its capabilities to...

Medicine Quality Must Be Assured, Not Assumed

Medicine Quality Must Be Assured, Not Assumed When a problem puts millions of lives at risk, costs economies billions of dollars and undermines decades of hard-earned health progress, it deserves prompt and strategic attention. I’m describing the consequences of poor-quality medicines – a worldwide problem that deserves worldwide attention. Yet in many public health policy discussions, it receives little, if any, consideration. Now is the time for us to prioritize the issue of...

The Role of Standards in Personalized Medicine

The Role of Standards in Personalized Medicine As personalized therapies have become a reality rather than a distant promise, the tools needed to ensure the quality of these medicines grow increasingly important. Regulatory guidances for personalized medicines are frequently a “work in progress,” evolving over time as the body of knowledge grows for ensuring that these therapies are safe and beneficial. Regulatory considerations for personalized medicines are often related to...

Digital Therapeutics: How to Ensure Quality in an Emerging Field

Digital Therapeutics: How to Ensure Quality in an Emerging Field Imagine using software on your phone or tablet to treat health conditions that, until now, could only be treated with medications. Now stop imagining, because for some conditions, such as attention deficit disorder and substance dependency, it is already a reality. I’m talking about the new field of digital therapeutics (DTx). The US Food and Drug Administration (FDA) has recently approved several of these digital...

Looking Ahead: Emerging Technologies and Quality Standards of Medicines

Looking Ahead: Emerging Technologies and Quality Standards of Medicines USP was founded nearly 200 years ago by eleven doctors who wanted to ensure that the nation had access to quality medicines. They put together the first pharmacopeia, a book of recipes for making tinctures, extracts, and other medicines. Then, in the mid-1800s, analytical chemistry evolved to enable quality testing. Fundamentally, medicine quality is concerned with the identity, strength, purity, and...

Quality medicines and sub-Saharan Africa

Quality medicines and sub-Saharan Africa Global health advocate Mirfin Moundu talks about the dangers of poor quality medicines and how they are a threat to many Africans in treating infectious diseases and non-communicable diseases. Stephanie Wagle Thu, 05/24/2018 - 16:43 Global Health ...

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