by The FDA has established a new safety-reporting paradigm for drugs being studied in clinical trials. A new regulation provides guidance on causality assessments for adverse events and requires aggre.. FDA Adverse Events Reporting System (FAERS) Public Dashboard. The FAERS public dashboard is a new, user-friendly and interactive web-based tool that was created to give the public the ability to query the FDA FAERS database and improve transparency. The data presented in the FAERS public dashboard has several key limitations.
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The FDA CFSAN Adverse Event Reporting System (CAERS) is a post-marketing surveillance system that receives and monitors adverse event and product complaint reports for foods, dietary supplements.. Meta-analyses of adverse events related to Doxil have primarily focused on side effects in ovarian cancer and breast cancer cardiotoxicity. In recurrent ovarian cancer, the toxicity profile of.
