The FDA typically inspects a drugmaker’s facility before it approves a new drug to determine if there are any quality issues in the manufacturing process. An inspection can determine whether a drugmaker has handled quality issues or is ignoring them. A FDA inspection recently found quality control issues with an Eli Lilly plant in New Jersey that makes its COVID-19 antibody drug.
But FDA regulations don’t require preapproval inspections for products seeking emergency use authorization, Jerry Weir, PhD, director of the division of viral products at the FDA told Bloomberg.
Moderna, one of the front-runners seeking authorization for a COVID-19 vaccine, was founded in 2010 and has never had a product gain FDA approval. It’s never been inspected by the FDA, Bloomberg reported.
Dr. Weir told Bloomberg that vaccine developers seeking emergency use authorization will have to submit complete details of their manufacturing process to show they’ve established a quality control unit.
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