FDA hands Liquidia and Revance a CRL and deferral, respectively, as Covid-19 creates inspection challenge
Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.
North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.
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