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GuidanceClassifying Significant PostmarketingDrug Safety IssuesDRAFT GUIDANCEThis guidance document is being distributed for comment purposes only. Comments and suggestions regarding this document
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What is classifying significant postmarketing?
Classifying significant postmarketing is the process of categorizing and identifying adverse events or drug reactions that occur after a drug has been approved and released to the market.
Who is required to file classifying significant postmarketing?
It is the responsibility of drug manufacturers, marketing authorization holders, or any other entity involved in the distribution of drugs to file classifying significant postmarketing.
How to fill out classifying significant postmarketing?
The process of filling out classifying significant postmarketing involves gathering relevant information about the adverse event or drug reaction, classifying it based on established criteria, and reporting it to the appropriate regulatory authorities.
What is the purpose of classifying significant postmarketing?
The purpose of classifying significant postmarketing is to identify and monitor adverse events or drug reactions that may not have been identified during the clinical trial phase, in order to ensure the safety and effectiveness of drugs in the market.
What information must be reported on classifying significant postmarketing?
The information that must be reported on classifying significant postmarketing includes details about the adverse event or drug reaction, such as the patient's information, the drug involved, the nature and severity of the event, and any actions taken.
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