Quality Matters | U.S. Pharmacopeia Blog

// June 17, 2024

Biologics and biosimilars – the basics

Biologic medicines – “biologics” for short. You’ve probably seen commercials for some of them on TV. Maybe you or someone you know is even taking one. But what exactly are they? And what about “biosimilars” ? You might also be wondering whether they’re safe and effective.

USP Staff

Producing maternal health supplies in sub-Saharan Africa

Global Health

// March 13, 2024

Producing maternal health supplies in sub-Saharan Africa ...

Understanding the landscape to expand, strengthen, and diversify African-based manufacturing

Perrer Tosso, Ph.D. Safia Ahsan

Medicines

// November 28, 2023

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards ...

This year has seen a flurry of activity by the U.S. Food and Drug Administration surrounding ophthalmic products.

Desmond Hunt Margareth Marques

Biologics

// June 17, 2024

Biologics and biosimilars – the basics

USP Staff

advancing pharmaceutical manufacturing in Africa

Global Health

// June 24, 2024

Advancing regional manufacturing in Africa: Four key takeaways from the 77th World He...

Expanding regional manufacturing in Africa relies on capable suppliers and a predictable demand. Following the World Health Assembly, we explore four ways to advance medicines manufacturing on the continent. Read the blog.

Emily Kaine, M.D. Allie Phillips

Supply Chain

// October 24, 2023

Why cancer medicines are and continue to be vulnerable to drug shortages...

Analysis leveraging USP’s Medicine Supply Map suggests many of the essential cancer medicines have inherently vulnerable supply chains and are at greater risk for shortage compared to other generic medicines.

Vimala Raghavendran Praewpaka Drucker

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Quality Medicines for Malaria

Global Health

// May 24, 2018

Quality Medicines for Malaria

Marie Lamy with Asia Pacific Leaders Malaria Alliance discusses how one country is tackling drug resistance in order to eradicate Malaria.

Poor quality medicines and drug resistance

Global Health

// May 24, 2018

Poor quality medicines and drug resistance

Harvard professor and physician Ashish Jha describes how poor quality medicines create the perfect opportunity for superbugs.

Quality medicines and sub-Saharan Africa

Global Health

// May 24, 2018

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.

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Republic of Korea’s (South Korea) National Institute of Food and Drug Safety Evaluation (NIFDS) at USP headquarters in Rockville, MD

Supply Chain

// September 10, 2024

Korea’s Minister of Food & Drug Safety: Addressing Medicines Supply Chain Resilience ...

Building on the momentum of recent high-level engagements with health agencies from around the world, USP hosted a delegation from the Republic of Korea’s (South Korea) National Institute of Food and Drug Safety Evaluation (NIFDS) at our U.S. hub in Rockville, MD.

Ron Piervincenzi, Ph.D.

Supply Chain

// September 09, 2024

Why Standards Matter in Digital Therapeutics

Maryland, MD—United States Pharmacopeia (USP) Healthcare Quality and Safety (HQS) Center of Excellence is examining the current landscape of Digital Therapeutics (DTx) to establish quality standards aimed at broadening access and ensuring appropriate use of these therapeutics.

Blaine Groat, PharmD, MS Yasmin Haidarbaigi, PharmD, PGPM

Reflecting on results from four years fighting TB in the Kyrgyz Republic

Global Health

// July 02, 2024

Reflecting on results from four years fighting TB in the Kyrgyz Republic ...

In 2022, more than 8,000 people in the Kyrgyz Republic developed tuberculosis (TB), including

Archil Salakaia Presha Regmi

Public Health advocates call on policymakers to end drug shortages in the U.S.

Supply Chain

// May 30, 2024

Public Health advocates call on policymakers to end drug shortages in the U.S. ...

Drug shortages pose a significant, ongoing threat to our healthcare system and to the patients who rely on medicine for their wellbeing and survival.

Amy Sonderman

Q&A with Mrunal Jaywant: How the Discovery of Nitrosamines in Medicines Shifted the Pharmaceutical Manufacturing Landscape

Supply Chain

// May 21, 2024

Q&A with Mrunal Jaywant: How the Discovery of Nitrosamines in Medicines Shifted the P...

In April, the World Health Organization (WHO) became the latest health authority to release a draft guidance on Current Good Manufacturing Practices (CGMP) considerations for the prevention and management of nitrosamine contamination in pharmaceutical products.

Mrunal Jaywant

Biologics

// May 21, 2024

Quality is a foundation for global vaccine preparedness...

The emergence of COVID-19 almost five years ago forced us all to face the realities of containing and mitigating a highly transmissible, deadly pandemic.

Diane McCarthy