US FDA On Resuming Normal Manufacturing Operations When Pandemic Recedes
Focus on restarting production, easing drug shortages and completing quality assurance activities for quarantined batches, agency guidance says.
You may also be interested in...
How pharmaceutical companies should plan to catch up after the pandemic and explain what happened to inspectors.
The US Food and Drug Administration has issued final guidance aimed at encouraging manufacturers of so-called "medically necessary drug products" and their raw materials and components to develop contingency production plans for use during emergencies that result in high absenteeism at production facilities.
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.