A recent article in the Journal of Pharmaceutical Innovation—titled “FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply”—explores the evolution of pharmaceutical regulation and the increasing challenges in maintaining drug quality in a globalized manufacturing landscape.

The article highlights alternative strategies from non-regulatory organizations, including Valisure and the University of Kentucky Drug Quality Study, which utilize end-product testing and screening to detect quality defects in medications already in circulation.

Valisure’s work is cited as a successful model for identifying serious issues in the U.S. drug supply, and the authors recommend that the FDA, large buyers, and the Department of Defense consider such approaches to complement existing regulatory oversight.

Read the full paper here.

A recent article in the Journal of Pharmaceutical Innovation—titled “FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply”—explores the evolution of pharmaceutical regulation and the increasing challenges in maintaining drug quality in a globalized manufacturing landscape.

The article highlights alternative strategies from non-regulatory organizations, including Valisure and the University of Kentucky Drug Quality Study, which utilize end-product testing and screening to detect quality defects in medications already in circulation.

Valisure’s work is cited as a successful model for identifying serious issues in the U.S. drug supply, and the authors recommend that the FDA, large buyers, and the Department of Defense consider such approaches to complement existing regulatory oversight.

Read the full paper here.