FDA drafts guid­ance on al­ter­nate elec­tron­ic for­mats, an­nounces sup­port for new da­ta stan­dards

The FDA on Tues­day is­sued draft guid­ance de­tail­ing an al­ter­nate elec­tron­ic for­mat for sub­mis­sions that qual­i­fy for an ex­emp­tion or waiv­er from elec­tron­ic com­mon tech­ni­cal doc­u­ment (eCTD) re­quire­ments.

Back­ground

The guid­ance comes less than a month af­ter the FDA fi­nal­ized the sev­enth re­vi­sion to its guid­ance on mak­ing reg­u­la­to­ry sub­mis­sions in eCTD for­mat to de­note when an ex­emp­tion or waiv­er from eCTD re­quire­ments is war­rant­ed.

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