Pandemic travel restrictions force FDA to delay a BLA review — involving a site inspection in Korea
In an unusual move, the FDA is apparently deferring action on a BLA because it was unable to conduct a manufacturing site inspection on time.
Spectrum Pharmaceuticals’ application for eflapegrastim is now in limbo as it works with the FDA to expedite its trip to the Hanmi plant in South Korea, where the drug substance is manufactured. Given pandemic travel restrictions, regulators were unable to inspect the site during the current review cycle, according to a statement put out Monday morning — two days after the original PDUFA date.
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