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.
In celebration of National Volunteer Week, USP is proud to recognize and honor the more than 640 volunteers who serve on USP’s standards-setting and advisory bodies—the USP Council of Expert, Expert Committees and Expert Panels. These dedicated individuals help USP fulfill its mission to improve global health by readily sharing their knowledge in the continuous revision of USP’s public standards that help ensure the quality of medicines, dietary supplements and foods.
Stakeholders representing major gummy manufacturers, ingredient manufacturers, contract laboratories, and trade associations recently participated in a USP roundtable discussion on gummy dietary supplements. They shared their views on technical and quality challenges in manufacturing as well as scientific and public health considerations related to the future development of USP quality standards for gummy dietary supplements.
Learn about USP's involvement in the APEC Life Sciences Innovation Forum and how this group is improving access to quality medical products by helping Asian-Pacific economies prevent, detect and respond to spurious, substandard, falsified, falsely-labelled and counterfeit products in their supply chains.