FDA Adverse Event Reporting System (FAERS) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse Event Data Reported to FAERS. [PDF]
Potter E, Reyes M, Naples J, Dal Pan G.
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After the green light: Evaluating drugs in Phase IV studies.
Meher BR, Mishra A.
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Challenges and future perspectives of enhanced passive safety surveillance of influenza vaccines in Europe. [PDF]
Amaral de Avila Machado M +6 more
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US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008-2022). [PDF]
Morrato EH +3 more
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Safety profile and potential clinical risks of xanomeline and trospium chloride: A real-world pharmacovigilance study using FAERS. [PDF]
Bao Z, Liu Y, Liu Y.
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Real-World Outcomes of Avelumab Maintenance Therapy in Patients With Curatively Unresectable Urothelial Carcinoma in Japan: Results From the Final Analysis of Postmarketing Surveillance. [PDF]
Kikuchi E +7 more
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Safety and Performance of Postmarketing Breast Implants: An Integrated Review with Technovigilance Data. [PDF]
Ramalho AAL +8 more
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Medication errors and associated serious outcomes in COVID-19 antivirals: a real-world study based on FDA Adverse Event Reporting System database. [PDF]
Xiong X, Chen Z, Yan B.
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