FDA won't require manufacturing inspections for emergency COVID-19 vaccine use: Bloomberg

As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections.

COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections, agency official Jerry Weir said at the FDA’s open meeting last week, according to Bloomberg. The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products.