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FDA supervisor: 'No LOA, no review' — letters of authorization required to access DMFs
Summary
Deborah Johnson of FDA OPQ told attendees that a letter of authorization (LOA) is required for the agency to access confidential drug master file (DMF) information and warned that missing LOAs can halt review timelines.
Deborah Johnson, supervisor in the Office of Pharmaceutical Quality Assessment 3 at the Food and Drug Administration, told attendees that the agency cannot access confidential drug master files without a signed letter of authorization. "No LOA, no review," she said, stressing that missing LOAs can halt or severely delay agency review.
Johnson explained that a DMF is a confidential submission containing manufacturing processes, control strategies, facilities and specifications and that LOAs are the formal permissions DMF holders sign to allow the FDA to reference that material in support of referencing applications. She illustrated the operational cost of missing LOAs with a recent example: "we burned up 3 days on a clock that was less than 8 days," after a secondary DMF lacked a submitted LOA and reviewers issued information requests.
She advised industry to include LOAs properly in electronic DMF filings and to keep LOAs up to date so reviewers do not have to stop a review to request missing or mismatched authorizations. Johnson closed by offering OPQ support for unusual LOA questions and providing the contact: "CDER OPQ inquiries at FDA.HHS.gov."
