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Food and Drug Administration, HHS if you are a producer complying with the requirements of this section as described in 118.1(a)(2). (4) Records of review and of modifications of the SE prevention
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What is 21cfr118 form?
21cfr118 form is a form used by pharmaceutical companies to report serious adverse events and product complaints to the Food and Drug Administration (FDA).
Who is required to file 21cfr118 form?
Pharmaceutical companies are required to file 21cfr118 form if they receive information regarding serious adverse events or product complaints related to their products.
How to fill out 21cfr118 form?
To fill out 21cfr118 form, pharmaceutical companies need to provide information about the involved product, the adverse event or complaint, the patient or complainant details, and any actions taken by the company to address the issue.
What is the purpose of 21cfr118 form?
The purpose of 21cfr118 form is to ensure that the FDA receives timely and accurate information about serious adverse events and product complaints, allowing the agency to monitor the safety and quality of pharmaceutical products.
What information must be reported on 21cfr118 form?
The information that must be reported on 21cfr118 form includes details about the product, such as its name, manufacturer, and lot number, as well as information about the adverse event or complaint, the patient or complainant, and any actions taken by the company.
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