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February 20, 2019
The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.
February 06, 2019
The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.
December 02, 2018
Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
October 02, 2018
Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
September 01, 2018
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
July 19, 2018
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
July 02, 2018
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
May 17, 2018
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
April 30, 2018
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.