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. |
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| 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 |
| ISSN: | 1549-8425 |
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| DOI: | 10.1097/PTS.0000000000001513 |
