FDA encourages collaboration between monoclonal antibody sponsors to keep pace with emerging Covid variants

The FDA is en­cour­ag­ing de­vel­op­ers of Covid-19 mon­o­clon­al an­ti­bod­ies to col­lab­o­rate and bet­ter tar­get emerg­ing vari­ants in fi­nal guid­ance pub­lished on Wednes­day.

The reg­u­la­tor ex­plained the emer­gency use au­tho­riza­tion de­c­la­ra­tion of the Food, Drug and Cos­met­ic Act is still in place even though the pub­lic health emer­gency has end­ed. The FDA ex­pects the spon­sors that re­ceive EUAs should con­tin­ue to col­lect da­ta and work to­ward sub­mit­ting their prod­ucts for full ap­proval “as soon as pos­si­ble.”

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