Tuesday, June 13, 2023

Drug Shortages - Part II (Quality Program)

Note: This article is the second entry of a series of mind maps listing actions that can be taken in various areas, that if/when taken and implemented collectively can contribute to systematically improving the situation.

Framework Needed:

I - Development/Implementation of New Capacity and Capabilities

II - FDA Quality Program

III - Transparency & End-to-End Visibility

IV - Ongoing Oversight and Reaction

V - Overall Coordination of Efforts

VI - Putting It All Together

Interesting development: Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot Study https://www.prnewswire.com/news-releases/valisure-signs-agreement-with-department-of-defense-to-independently-test--quality-score-drugs-301895301.html