An all-too-familiar experience in recent years, medicines supply chain disruptions can arise from many factors, including pandemics like COVID-19, natural disasters, and geopolitical events like those taking place right now in Eastern Europe.
We need to reduce the barriers to adoption of advanced manufacturing technology (AMT) like pharmaceutical continuous manufacturing (PCM).
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.
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.
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.