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All Serious Adverse Events must be reported within 24 hours after onset. Please email the SAE to drigitat@amc.nlA follow-up report must be sent within 7 days and final report when outcome of SAE is
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21 CFR 314.80 is a regulation issued by the U.S. Food and Drug Administration (FDA) that governs the content and format of new drug applications (NDAs).
Pharmaceutical companies seeking FDA approval for new drugs are required to file 21 CFR 314.80.
To fill out 21 CFR 314.80, pharmaceutical companies must provide detailed information about the new drug, its safety and efficacy data, manufacturing methods, labeling, and more.
The purpose of 21 CFR 314.80 is to ensure that new drug applications submitted to the FDA contain all necessary information for the agency to make an informed decision on the approval of the drug.
Information such as data from preclinical and clinical studies, drug labeling, manufacturing methods, packaging, and proposed post-marketing studies must be reported on 21 CFR 314.80.
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