Generic Firms Want Congress To Build On CARES Act To Prevent Critical Drug Shortages
The association for manufacturers of generics and biologics calls for public sector investment in priority medicines.
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Pharmaceutical supply chains may grow less efficient and less risk prone as US government gets more involved to ensure availability of pandemic and essential medicines. But what about pediatric oncology medicines and other treatments that save lives even though they may not be considered essential?
Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.
Manufacturers could risk losing FDA product approvals if they fail to publicize sourcing and quality information, under new proposals. National Academies expert panel says supply chain transparency – not a pandemic-induced rush to onshoring requirements – provides the framework to mitigate against and respond to drug shortages.