Hi Ruth, I've stopped sending the field notification letters since all now have access to the electronic submissions.
Instead, I put the following in Section 1.3.2, Field Copy Certification:
"In accordance with 21 CFR 314.54(a)(4) and FDA Guidance for Industry: Providing Regulatory
Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and
Related Submissions Using the eCTD Specifications Guidance for Industry, February 2020, we
ask that the Electronic Document Room forward a copy of this submission to the applicable FDA
District Office(s)."
Hope this helps!
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Janet DeLeon
CEO
DeLeon Pharmaceutical Consulting, LLC
janet@deleonpharma.com------------------------------
Original Message:
Sent: 11-Jul-2023 13:46
From: Ruth Collins
Subject: Field Office Letter for Foreign Sites
We are submitting an ANDA for a client. The client is US-based, but the drug product manufacturer is based in another country. For the Field Office letters, we will send one to the Field Office for the client's area; however, where would I send a letter for the foreign-based manufacturing company? Do we even need to send one for the Field Certification?
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Ruth Collins RAC
Manager Regulatory Affairs
Fort Worth TX
United States
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