Do I need to register each single-patient investigational new drug application (IND) or protocol exception (including for emergency use) separately? 1.56K viewsOctober 10, 2022FDA 0 Sam Smith11.38K September 24, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted September 24, 2020 0 Comments Spread the loveNo, manufacturers or Sponsors accepting requests for single-patient investigational new drug applications (INDs) or protocol exceptions (including for emergency use) should provide only one expanded access record. Spread the love Login