As the impact of the COVID-19 pandemic continues to unfold, each day brings to light new realizations of just how interconnected, and sometimes vulnerable, the global supply chain for medicines is.
The COVID-19 pandemic has presented unprecedented challenges around the world, including to national public health systems and the international biopharmaceutical industry.
I was pleased to address the American Association of Pharmaceutical Scientists (AAPS) on May 12 during a webinar focused on the impact of the COVID-19 pandemic on the supply of quality medicines.
Today, many critical, life-saving medicines go through a complex global supply chain before ever reaching the patient. USP’s public standards play important roles throughout that supply chain. Learn more.
For a hundred years, federal law has required that all drugs adhere to public quality standards—part of ensuring safety and protecting the public’s health. Language that would exempt biologics, including biosimilars, from adhering to the same public quality standards as other prescription medicines was recently added to the FDA and NIH Workforce Authorities Modernization Act. Learn about the potential impact this biologics quality exemption may have on competition, product development, and the public's confidence in biologics and biosimilars.
New USP Food Fraud Mitigation Guidance aims to help manufacturers and regulators identify ingredients most vulnerable to fraud in their supply chains and choose effective mitigation tools to combat economically-motivated adulteration.
For the first time in more than 20 years, U.S. regulators are considering the reintroduction of bovine (cow-derived) heparin into the U.S., helping to address concerns about potential shortages and adulteration issues associated with this widely-used drug.
India is a prominent player in today’s global pharmaceutical arena and a major contributor to the world’s supply of medicines. A large number of generics and OTC medicines in the U.S. are imported from India, which makes USP's collaborations with Indian pharma critical.
Intentional deception using food for economic gain, or food fraud, has been an ongoing challenge since the beginning of the food and drink industry.