FDA to al­low on­line sub­mis­sions of or­phan des­ig­na­tion re­quests

As part of work build­ing on the FDA’s or­phan drug mod­ern­iza­tion plan from 2017, the agency said Fri­day that lat­er this year it will move from a pa­per-based process to a new cloud-based on­line sub­mis­sion por­tal for or­phan drug des­ig­na­tion re­quests.

The shift to on­line sub­mis­sions will ease the process of mak­ing or­phan drug des­ig­na­tion re­quests, which are cur­rent­ly mailed in­to the Of­fice of Or­phan Prod­ucts De­vel­op­ment (OOPD) on a CD.

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