FDA re­vamps ad­verse event re­port­ing guid­ance for Covid-19

The FDA on Thurs­day re­vised its guid­ance on post­mar­ket ad­verse event re­port­ing for med­ical prod­ucts and di­etary sup­ple­ments dur­ing a pan­dem­ic to ap­ply the guid­ance to the on­go­ing coro­n­avirus dis­ease (Covid-19) pan­dem­ic.

The guid­ance, which ap­plies to drugs, bi­o­log­ics, med­ical de­vices, com­bi­na­tion prod­ucts and sup­ple­ments, de­tails how FDA in­tends to pri­or­i­tize ad­verse event re­port­ing re­quire­ments dur­ing a pan­dem­ic.

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