Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Loa Maintenance topic
No spam. Unsubscribe anytime.
Keep LOAs current when names or authorizations change, FDA advises
Summary
FDA OPQ urged firms to update LOAs and DMF lists of authorized parties after company name changes or authorization removals so reviewers do not have to pause reviews to request corrections.
Johnson stressed that LOAs are 'living documents' that must be updated when an authorized party's name or a DMF holder's company name changes. She said a name mismatch between an LOA and a referencing application commonly forces reviewers to pause and send information requests to reconcile the records.
She recommended submitting a new LOA with the updated name to the DMF and to any applicable referencing applications. Johnson said keeping lists current avoids unnecessary stops in the review and repeated communications. She also acknowledged Melissa Furnas in OPQ policy for assistance with LOA issues.
