FDA to re­quire cer­tain IND safe­ty re­ports be sub­mit­ted to FAERS

The FDA on Tues­day is­sued draft guid­ance re­quir­ing spon­sors to sub­mit in­ves­ti­ga­tion­al new drug (IND) safe­ty re­ports for se­ri­ous and un­ex­pect­ed sus­pect­ed ad­verse events …

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