Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the ESubmission Instructions topic
No spam. Unsubscribe anytime.
Where to place LOAs in e-submissions: OPQ guidance for DMF holders
Summary
FDA OPQ advised that LOAs should appear in specific e-submission sections (1.4.1 or 1.4.3) and that reviewers check these sections first when starting a review.
Deborah Johnson advised DMF holders on the correct placement of letters of authorization in electronic submissions, saying reviewers open specific sections to determine review scope. She said LOAs that authorize others to reference your DMF belong in e-submission section 1.4.1 and LOAs that allow you to reference another party belong in section 1.4.3.
Johnson said placing LOAs in the correct e-submission sections speeds reviewer access to required information: "when we start a review, the 1st place we go to, these sections. It's the 1st place we open it up because it lets us know right off the bat how much work is involved." She recommended consistent placement to reduce unnecessary information requests and review delays.
