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.  ..read more

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.  ..read more

The American drug supply is among the safest in the world, with many protections for consumers and patients.  However, a pending proposal in Congress would remove key protections for all biologic drugs—crucial and lifesaving medicines we take like insulin, human growth hormones, and blood thinners ..read more

Anita Szajek, Ph.D., principal scientific liaison to USP’s Expert Panel on Therapeutic Peptides, examines therapeutic peptides, the transition from recombinant to synthetic manufacturing routes, and regulatory and quality-related questions ..read more

Legislation being considered by Congress will remove the requirement that all biologic medicines – drugs such as insulin, vaccines, cancer treatments and other therapies made using living matter – comply with public quality standards of the U.S. Pharmacopeia (USP). This same legislation would also apply to biosimilars. As a result, public confidence in biologics and biosimilars as well as patient safety would be at risk ..read 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 ..read more

Anita Szajek, Ph.D., principal scientific liaison to USP’s Expert Panel on Therapeutic Peptides, examines therapeutic peptides, the transition from recombinant to synthetic manufacturing routes, and regulatory and quality-related questions ..read more

Legislation being considered by Congress will remove the requirement that all biologic medicines – drugs such as insulin, vaccines, cancer treatments and other therapies made using living matter – comply with public quality standards of the U.S. Pharmacopeia (USP). This same legislation would also apply to biosimilars. As a result, public confidence in biologics and biosimilars as well as patient safety would be at risk ..read 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 ..read more

The American drug supply is among the safest in the world, with many protections for consumers and patients.  However, a pending proposal in Congress would remove key protections for all biologic drugs—crucial and lifesaving medicines we take like insulin, human growth hormones, and blood thinners ..read more