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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