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Postmarketing Safety Concerns With FDA Black Box Warning Monoclonal Antibodies: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System Database.

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Title: Postmarketing Safety Concerns With FDA Black Box Warning Monoclonal Antibodies: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System Database.
Authors: Kalaivani K; Department of Pharmacy Practice, SRM College of Pharmacy, Faculty of Medicine and Health Sciences, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, India.; Quality Assurance Department, Scitus Pharma Services Private Limited, Chennai, Tamil Nadu, India., Chandrasekaran S; Department Head of Clinical Research, Scitus Pharma Services Private Limited, Chennai, Tamil Nadu, India., Rajendran SD; Head Operations, Scitus Pharma Services Private Limited, Chennai, Tamil Nadu, India., Munishwararaj V; Biostatistician, Scitus Pharma Services Private Limited, Chennai, Tamil Nadu, India., Vijayakumar TM; Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, India.
Source: Journal of patient safety [J Patient Saf] 2026 May 11. Date of Electronic Publication: 2026 May 11.
Publication Type: Journal Article
Journal Info: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 101233393 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-8425 (Electronic) Linking ISSN: 15498417 NLM ISO Abbreviation: J Patient Saf Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Kalaivani+K%22">Kalaivani K</searchLink>; Department of Pharmacy Practice, SRM College of Pharmacy, Faculty of Medicine and Health Sciences, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, India.; Quality Assurance Department, Scitus Pharma Services Private Limited, Chennai, Tamil Nadu, India.<br /><searchLink fieldCode="AU" term="%22Chandrasekaran+S%22">Chandrasekaran S</searchLink>; Department Head of Clinical Research, Scitus Pharma Services Private Limited, Chennai, Tamil Nadu, India.<br /><searchLink fieldCode="AU" term="%22Rajendran+SD%22">Rajendran SD</searchLink>; Head Operations, Scitus Pharma Services Private Limited, Chennai, Tamil Nadu, India.<br /><searchLink fieldCode="AU" term="%22Munishwararaj+V%22">Munishwararaj V</searchLink>; Biostatistician, Scitus Pharma Services Private Limited, Chennai, Tamil Nadu, India.<br /><searchLink fieldCode="AU" term="%22Vijayakumar+TM%22">Vijayakumar TM</searchLink>; Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, India.
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        Value: 10.1097/PTS.0000000000001513
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        Text: English
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      – TitleFull: Postmarketing Safety Concerns With FDA Black Box Warning Monoclonal Antibodies: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System Database.
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            – D: 11
              M: 05
              Text: 2026 May 11
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