Generics
Complex generics: Are global regulators addressing the needs? ...
The development of generic versions of innovator medicines is a global public health need.
Complex generics: The need and challenges
Generic medicines have benefited millions of Americans and saved trillions of dollars.
Compendium, compendia, compendial: Clearing up the mystery of these terms...
In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary.
Generic drugs: New approaches to maximize competition, lower prices and increase acce...
Building the marketplace for generic medicines is a key strategy to containing drug costs in the US, one that USP actively supports through our standards-setting work.
USP Congratulates Margaret Hamburg on Her Successful Tenure at the FDA...
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.
Ensuring the Quality of Synthetic Peptides
Today, peptides represent one of the fastest growing segments in the pharmaceutical market. Hence, being able to manufacture peptides that are consistent in makeup and quality is an important priority for manufacturers of this drug class. This article discusses how the global pharmaceutical landscape continues to transform and how quality standards will play a growing role in the manufacture of these drugs.
Do You Find Prescription Labels Hard to Read? You Are Not Alone...
Each year, over a million Americans experience a health problem because they find their prescription labels difficult to read or understand. This article explores some of the common mistakes patients make when taking their medicines, and offers patient centered guidelines to help standardize and simplify prescription label information.
Quality Medicines are Key In the Fight Against Tuberculosis (TB) ...
Tuberculosis (TB) is one of the world’s most prevalent diseases – it kills three people every minute. Although progress has been made in expanding access to treatment, the rate of multi-drug resistant TB cases has nearly doubled between 2011 and 2012. One factor driving drug resistance is poor quality drugs. Several global health organizations have partnered together to find a solution to ensure that safe and effective medicines are used in their treatment programs.