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Transmucosal ImmediateRelease REMS Advisory Committee Briefing DocumentANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY COMMITTEE (AAD PAC) AND DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE (DISARM)
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Drug safety is the process of monitoring the effects of medications and ensuring their safe use.
Manufacturers, healthcare providers, and regulatory agencies are required to file drug safety reports.
Drug safety reports are typically filled out electronically through a specific reporting system.
The purpose of drug safety reporting is to identify and prevent adverse reactions to medications.
Information such as the patient's details, the drug name, dosage, adverse reaction, and outcome must be reported on drug safety reports.
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