Drugmakers Urged to Develop Early Plans for Averting Shortages

Drugmakers should create plans early on in their product’s development stages to mitigate supply disruptions and shortages, the FDA said Thursday in draft guidance.

The recommendations outline the steps sponsors of drug or biologic applications should take to develop risk management plans that could limit the impacts of quality issues. The draft guidance is part of a coordinated effort by the Food and Drug Administration to better prepare for future issues in pharmaceutical supply following pandemic-fueled shortages.

Effective risk management plans “can facilitate better, more informed decisions,” and “can provide FDA with greater assurance that stakeholders understand and can manage ...