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FDA lists IID resources, mailbox routes and limits on inquiries
Summary
The presenter directed attendees to IID guidance, FAQs and the quarterly change log, provided contact emails for general IID inquiries and nomenclature corrections and said application‑specific questions should go through control correspondence (60‑day turnaround); she cautioned that proprietary product formulations will not be disclosed.
The presenter closed with practical resources for IID users and clarified what the IID mailbox can and cannot answer. She pointed to the IID search page, draft guidance, FAQs and the quarterly change log and provided contact routes for different types of inquiries.
"If you do have any questions, which we do get a lot of questions, we welcome those... For any application specific questions related to the use of excipients in generic products...there is a 60 day turnaround for those," the agency official said, and she warned that the IID mailbox will not accept inquiries that would disclose proprietary reference formulations or proprietary product information.
