FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA an­nounced to­day that doc­tors and phar­ma­cists can now pre­scribe Paxlovid to pa­tients with­out a pos­i­tive test for Covid-19.

CDER Di­rec­tor Pa­trizia Cavaz­zoni reis­sued Paxlovid’s au­tho­riza­tion let­ter Wednes­day, say­ing it has re­vised the au­tho­riza­tion to “no longer re­quire pos­i­tive re­sults of di­rect SARS-CoV-2 vi­ral test­ing.” The EUA now re­quires in­stead that adults and kids 12 years of age and old­er have a “cur­rent di­ag­no­sis of mild-to-mod­er­ate COVID-19.”

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