Drug Shortages: Would Sponsors Admit Their Products Are Vulnerable?
US FDA's upcoming drug shortage risk criteria will be made public and sponsors could be asked to find the vulnerable products in their portfolios.
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Could US Solve Drug Shortages With 'Heightened' M&A Scrutiny?
FDA's inter-agency drug shortage task force wants comments on whether new shortage prevention and mitigation policies should include closer examination of mergers and acquisitions that could create drug shortages.
Who Wants To Be 'Essential'? US FDA Considers Critical Drugs List
To address chronic shortages, FDA may create list of 'essential' drugs, but will suppliers of those products be happy to be designated 'essential'?
FDA Shortages Task Force Looks More Broadly To Tackle Root Causes
FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.