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 to the FDA Ad­verse Event Re­port­ing Sys­tem (FAERS) start­ing 24 months af­ter the guid­ance is fi­nal­ized.

Cur­rent­ly, such re­ports are sub­mit­ted to the FDA in elec­tron­ic com­mon tech­ni­cal doc­u­ment (eCTD) for­mat us­ing PDF files, which the FDA says are “in­ef­fi­cient and la­bor in­ten­sive” to re­view and track.

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