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.
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.
USP's CEO Dr. Ron Piervincenzi relays his experiences and lessons learned from the 68th World Health Assembly held in Geneva, Switzerland, which he recently attended as a private advisor to the U.S. delegation led by Secretary of Health and Human Services, Sylvia Burwell.
Margaret Hamburg is approaching the end of a successful six-year tenure as Commissioner of the U.S. Food and Drug Administration. USP extends its congratulations to Dr. Hamburg in this letter from CEO Ron Piervincenzi.
Access to quality care and medicines is an integral part of public health. For USP, an organization that creates and promotes public standards for medicines and foods, quality and access are two sides of the same coin and in fact the absence of either one actually threatens effectiveness of medical care around the world.
When is the last time you considered the importance of quality medicines and foods? For nearly 200 years USP has been setting quality standards and we are committed to improving global health through public standards that help ensure the quality, safety and benefits of these essential products.