Results 151 to 160 of about 478,778 (207)

Analysis of Adverse Events Reports Submitted to the Food and Drugs Administration of the United States of America (2007-2012)

, 2019
Emmanuel M. Baah
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Suspected adverse drug reactions of rivaroxaban reported in the United States food and drug administration adverse event reporting system database: a pharmacovigilance study

Jingying Wu, Jianru Wu, Biyu Tang, Xinru Wang, Fenfang Wei, Yi Zhang, Limin Li, Hongqiao Li, Bei Wang, Wenyu Wu, Xiang Hong   +10 more
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Drug-associated congenital anomalies of the external ear identified in the United States food and drug administration adverse event reporting system database

Xinyu Li, Jiajia Hao, Datao Li, Ruhong Zhang   +3 more
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An Overview of the Recent Use of Novel Data Streams During Foodborne Illness Cluster Investigations by the United States Food and Drug Administration (Preprint)

Michael C. Bazaco, Christina K. Carstens, Tiffany Greenlee, Tyann Blessington, Evelyn Pereira, Sharon L. Seelman, Stranjae Ivory, Temesgen Jemaneh, Margaret Kirchner, Alvin Crosby, Stelios Viazis, Sheila van Twuyver, Michael Gwathmey, Tanya Malais, Oliver Ou, Stephanie Kenez, Nichole Nolan, Andrew Karasick, Cecile Punzalan, Colin Schwensohn, Laura Gieraltowski, Cary Chen Parker, Erin Jenkins, Stic Harris   +23 more
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United States Food and Drug Administration Drug Approval Summary [PDF]

Clinical Cancer Research, 2004
Abstract On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
Richard T. Lostritto, David L. Morse, Grant A. Williams, Sophia Abraham, Rajeshwari Sridhara, W. David McGuinn, Chenyi Liang, Atiqur Rahman, Amy Baird, Martin H. Cohen, Gang Chen, Richard Pazdur   +11 more
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Oncology drug development: United States Food and Drug Administration perspective

Critical Reviews in Oncology/Hematology, 2002
The Food and Drug Administration (FDA) in the United States has multiple roles. The primary responsibilities for oncology drug products are the supervision of clinical research, the evaluation of marketing claims for new and previously approved drugs, the granting of exclusive marketing licenses for approved claims, and the monitoring of post-marketing
Steven Hirschfeld, Richard Pazdur
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Analysis of adverse events with sclerosants reported to the United States Food and Drug Administration

Phlebology: The Journal of Venous Disease, 2022
Objectives To analyze adverse events (AEs) related to sclerosants reported through the Federal Adverse Event Reporting System (FAERS). Methods We queried the FAERS database for all cases associated with sclerosants. Reports were analyzed and stratified based on severity of cases and patient death.
Christopher N Nguyen, Quoc-Bao D Nguyen, Sirunya Silapunt   +2 more
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End Points and United States Food and Drug Administration Approval of Oncology Drugs

Journal of Clinical Oncology, 2003
Purpose: To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years. Materials and Methods: The FDA granted marketing approval to 71 oncology drug applications between January 1, 1990, and November 1, 2002.
John R. Johnson, Grant A. Williams, Richard Pazdur   +2 more
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Retrospective analysis of adverse events with dupilumab reported to the United States Food and Drug Administration

Journal of the American Academy of Dermatology, 2021
Atopic dermatitis (AD) is one of the most common inflammatory skin diseases and has aesthetic, physical, and emotional-social sequelae when left untreated.To classify the most common adverse reactions associated with dupilumab treatment in patients with AD.The United States Food and Drug Administration Adverse Event Reporting (FAERS) database was ...
Joseph L. Jorizzo, Joseph L. Jorizzo, Yu Wang   +2 more
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The United States Food and Drug Administration’s Risk Management Framework

Drug Information Journal, 2002
In response to criticism that under the Prescription Drug User Fee Act, the United States Food and Drug Administration was endangering public health by shortening the review and approval process for medical products, former Food and Drug Administration Commissioner Jane Henney appointed a task force to evaluate the effectiveness of the Food and Drug ...
Gina Steidle, Shawn E. Hodges
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