FDA un­veils guid­ance for Covid-19 tri­als

The FDA on Wednes­day is­sued new fi­nal guid­ance to help spon­sors as­sure the safe­ty of tri­al par­tic­i­pants, main­tain com­pli­ance with good clin­i­cal prac­tice (GCP) and min­i­mize the risks to tri­al in­tegri­ty dur­ing the Covid-19 pan­dem­ic.

The guid­ance comes as the Na­tion­al In­sti­tutes of Health last week ini­ti­at­ed the first Covid-19 vac­cine Phase 1 tri­al in Seat­tle. Sanofi and Re­gen­eron Phar­ma­ceu­ti­cals al­so an­nounced on Mon­day they have start­ed a Phase 2/3 tri­al at med­ical cen­ters in New York eval­u­at­ing the IL-6 tar­get­ed Kevzara (sar­ilum­ab) in pa­tients hos­pi­tal­ized with se­vere Covid-19.

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