FDA is­sues two guid­ances to ac­cel­er­ate Covid-19 treat­ments

The FDA on Mon­day evening is­sued two guid­ances in­tend­ed to ac­cel­er­ate the de­vel­op­ment of prod­ucts to treat or pre­vent coro­n­avirus dis­ease (Covid-19), lay­ing out rec­om­men­da­tions to help com­pa­nies get to the in­ves­ti­ga­tion­al new drug ap­pli­ca­tion (IND) stage and clin­i­cal tri­al de­sign con­sid­er­a­tions for lat­er-stage stud­ies.

“Ac­cel­er­at­ing the in­ves­ti­ga­tion of safe and ef­fec­tive ther­a­pies that could ben­e­fit peo­ple af­fect­ed by the COVID-19 pan­dem­ic is one of the FDA’s high­est pri­or­i­ties. We are com­mit­ted to max­i­miz­ing our reg­u­la­to­ry flex­i­bil­i­ty and us­ing every tool at our dis­pos­al to speed the de­vel­op­ment and avail­abil­i­ty of these med­ical prod­ucts and be­lieve these new guid­ances will help in­no­va­tors and re­searchers do just that,” said FDA Com­mis­sion­er Stephen Hahn.

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