Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment.
Huang J, Su A, Yang J, Zhuang W, Li Z.
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Fibrosing colonopathy associated with cysteamine bitartrate delayed-release capsules in cystinosis patients. [PDF]
Kishk OA+4 more
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Has risk management plan system influenced the speed of package insert revisions in Japan? [PDF]
Kameyama N, Hosaka A, Maeda H.
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Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation. [PDF]
Lomeli-Silva A+4 more
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Overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: a scoping review using a systematic approach. [PDF]
Wang RQ, Bonomo YA, Hallinan CM.
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Navigating Oncology Clinical Trials: From Drug Development to Delivery. [PDF]
Bourgeois J, Goodman MS, Braga C.
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Response to Xing et al.: post-marketing safety concerns with Lecanemab: a pharmacovigilance study based on the FDA adverse event reporting system database. [PDF]
Irizarry M+3 more
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The FDA and the Tort System: Postmarketing Surveillance, Compensation, and the Role of Litigation [PDF]
Struve, Catherine T
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Long-term surveillance of the anti-amyloid monoclonal antibody lecanemab: rights and duties of pharmacovigilance. [PDF]
Donati M+4 more
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Real-World Use of Ruxolitinib Cream: Safety Analysis at 1 Year. [PDF]
Hu W, Thornton M, Livingston RA.
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