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Initial REMS Approval: 12/2011 PROPOSED TRANSMUCOSAL IMMEDIATE RELEASE (TIRE) RISK EVALUATION AND MITIGATION STRATEGY (REMS) Page 1 of 13 Reference IDs: 3064647 I. GOALS The goals of the TIRE REMS
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What is rems - food and?
rems - food and is a regulatory reporting system used for reporting food and dietary supplement adverse events.
Who is required to file rems - food and?
Manufacturers, packers, and distributors of food and dietary supplements are required to file rems - food and.
How to fill out rems - food and?
rems - food and can be filled out online through the FDA's electronic submission portal.
What is the purpose of rems - food and?
The purpose of rems - food and is to monitor and report adverse events related to food and dietary supplements.
What information must be reported on rems - food and?
Information such as the product name, adverse event description, patient demographics, and contact information must be reported on rems - food and.
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