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 …

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