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.

“Sub­mis­sion of this im­por­tant safe­ty in­for­ma­tion to FAERS as struc­tured da­ta el­e­ments will im­prove the FDA’s abil­i­ty to re­view and track these po­ten­tial safe­ty sig­nals that oc­cur dur­ing the con­duct of clin­i­cal tri­als, and will pro­vide spon­sors with a re­port­ing for­mat that is con­sis­tent with In­ter­na­tion­al Coun­cil for Har­mon­i­sa­tion (ICH) guide­lines and re­port­ing re­quire­ments to oth­er reg­u­la­to­ry agen­cies,” the FDA writes.

The switch to sub­mit­ting IND safe­ty re­ports for se­ri­ous and un­ex­pect­ed sus­pect­ed ad­verse events is part of the FDA’s ef­fort to im­ple­ment the elec­tron­ic sub­mis­sion re­quire­ments of Sec­tion 745A(a) of the Fed­er­al Food, Drug, and Cos­met­ic Act.

While fed­er­al agen­cies are not typ­i­cal­ly able to es­tab­lish new re­quire­ments via guid­ance, Con­gress gave the FDA ex­plic­it au­tho­riza­tion to do so to es­tab­lish the for­mat for elec­tron­ic sub­mis­sions un­der Sec­tion 745A(a).

For now, the FDA says spon­sors will be able to con­tin­ue sub­mit­ting such IND safe­ty re­ports via eCTD, though spon­sors may vol­un­tar­i­ly sub­mit the re­ports to FAERS be­fore the re­quire­ment is in ef­fect.

Once ef­fec­tive, the guid­ance will su­per­sede the FDA’s fi­nal guid­ance Pro­vid­ing Reg­u­la­to­ry Sub­mis­sions in Elec­tron­ic For­mat — Cer­tain Hu­man Phar­ma­ceu­ti­cal Prod­uct Ap­pli­ca­tions and Re­lat­ed Sub­mis­sions Us­ing the eCTD Spec­i­fi­ca­tions for IND safe­ty re­ports that fall with­in the scope of the new guid­ance.

Un­der the pol­i­cy laid out in the guid­ance, spon­sors must sub­mit IND safe­ty re­ports to FAERS via the FDA’s Elec­tron­ic Sub­mis­sion Gate­way (ESG) or Safe­ty Re­port­ing Por­tal (SRP).

The FDA notes that the guid­ance does not ap­ply to IND safe­ty re­ports for any­thing oth­er than se­ri­ous and un­ex­pect­ed sus­pect­ed ad­verse events, such as re­ports de­tail­ing find­ings from oth­er stud­ies, find­ings from an­i­mal or in vit­ro test­ing or of in­creased rate of oc­cur­rence of se­ri­ous sus­pect­ed ad­verse re­ac­tions.

Ad­di­tion­al­ly, the FDA says that sub­mis­sions for non­com­mer­cial INDs will be ex­empt from the elec­tron­ic sub­mis­sion re­quire­ments un­der Sec­tion 745A(a), though the agency en­cour­ages such spon­sors to do so.

Along­side the draft guid­ance, the FDA is­sued a sep­a­rate tech­ni­cal con­for­mance guide meant to sup­ple­ment the draft guid­ance by de­tail­ing the for­mat that should be used for IND safe­ty re­ports sub­mit­ted to FAERS as in­di­vid­ual case safe­ty re­ports (IC­SRs) and IND safe­ty re­ports that should be sub­mit­ted to the FDA in elec­tron­ic com­mon tech­ni­cal doc­u­ment (eCTD) for­mat.


RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion

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