Charles Bennett to United States Food and Drug Administration
This is a "connection" page, showing publications Charles Bennett has written about United States Food and Drug Administration.
Connection Strength
5.507
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Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions. Lancet Oncol. 2020 12; 21(12):e575-e588.
Score: 0.659
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Fluoroquinolone-associated suicide. Eur J Intern Med. 2018 09; 55:e21-e22.
Score: 0.559
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Federal 340B Program Payment Scheme for Drugs Designated As Orphan Products: Congressional Clarification Needed to Close the Government-Industry Revolving Door. J Clin Oncol. 2016 12 20; 34(36):4320-4322.
Score: 0.496
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Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis. PLoS One. 2016; 11(5):e0155259.
Score: 0.481
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A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report. J Oncol Pract. 2012 Nov; 8(6):e158-67.
Score: 0.371
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Description of anaphylactic reactions to paclitaxel and docetaxel reported to the FDA, with a focus on the role of premedication. Expert Opin Drug Saf. 2011 Jul; 10(4):521-8.
Score: 0.340
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Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs? J Clin Oncol. 2009 Sep 10; 27(26):4398-405.
Score: 0.300
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Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Arch Intern Med. 2007 May 28; 167(10):1041-9.
Score: 0.258
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Translating Research into Health Policy: The Citizen Petition Experience with the Food and Drug Administration. Cancer Treat Res. 2022; 184:61-73.
Score: 0.178
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Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. PLoS One. 2019; 14(7):e0219521.
Score: 0.150
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Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada. Oncologist. 2019 04; 24(4):537-548.
Score: 0.146
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Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition. Drugs. 2018 Nov; 78(17):1777-1781.
Score: 0.143
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Reply to A.M. Zeidan et al. J Clin Oncol. 2017 10 01; 35(28):3265.
Score: 0.131
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Effects of the US Food and Drug Administration Boxed Warning of Erythropoietin-Stimulating Agents on Utilization and Adverse Outcome. J Clin Oncol. 2017 Jun 10; 35(17):1945-1951.
Score: 0.128
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Detection of cases of progressive multifocal leukoencephalopathy associated with new biologicals and targeted cancer therapies from the FDA's adverse event reporting system. Expert Opin Drug Saf. 2016 Aug; 15(8):1003-11.
Score: 0.121
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FDA Approval of Extended-Release Oxycodone for Children With Severe Pain. Pediatrics. 2016 05; 137(5).
Score: 0.120
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Evaluation of gemtuzumab ozogamycin associated sinusoidal obstructive syndrome: Findings from an academic pharmacovigilance program review and a pharmaceutical sponsored registry. Leuk Res. 2016 May; 44:61-4.
Score: 0.119
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Fluoroquinolone-associated tendon-rupture: a summary of reports in the Food and Drug Administration's adverse event reporting system. Expert Opin Drug Saf. 2015; 14(11):1653-60.
Score: 0.115
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Underreporting of hemorrhagic and thrombotic complications of pharmaceuticals to the U.S. Food and Drug Administration: empirical findings for warfarin, clopidogrel, ticlopidine, and thalidomide from the Southern Network on Adverse Reactions (SONAR). Semin Thromb Hemost. 2012 Nov; 38(8):905-7.
Score: 0.094
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Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet Oncol. 2008 Dec; 9(12):1166-72.
Score: 0.072
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Adverse effects of drugs used to treat hematologic malignancies: surveillance efforts from the research on adverse drug events and reports project. Semin Thromb Hemost. 2007 Jun; 33(4):365-72.
Score: 0.065
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Long-term outcome of individuals with pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant epoetin: a follow-up report from the Research on Adverse Drug Events and Reports (RADAR) Project. Blood. 2005 Nov 15; 106(10):3343-7.
Score: 0.057
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Serious adverse cutaneous and hepatic toxicities associated with nevirapine use by non-HIV-infected individuals. J Acquir Immune Defic Syndr. 2004 Feb 01; 35(2):120-5.
Score: 0.051
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Clopidogrel-associated TTP: an update of pharmacovigilance efforts conducted by independent researchers, pharmaceutical suppliers, and the Food and Drug Administration. Stroke. 2004 Feb; 35(2):533-7.
Score: 0.051
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Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports project. J Clin Oncol. 2003 Oct 15; 21(20):3859-66.
Score: 0.050
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Medicare Spending on Drugs With Accelerated Approval. Ann Intern Med. 2022 07; 175(7):938-944.
Score: 0.046
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Single-arm clinical trials that supported FDA accelerated approvals have modest effect sizes and were at high risk of bias. J Clin Epidemiol. 2022 08; 148:193-195.
Score: 0.045
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Response to: letter to the editor: consideration on 'an evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the food and drug administration and the European medicines agency' by bennett et al. Expert Opin Drug Saf. 2020 08; 19(8):1057-1058.
Score: 0.040
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An evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin-association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the Food and Drug Administration and the European Medicines Agency. Expert Opin Drug Saf. 2019 Nov; 18(11):1055-1063.
Score: 0.038
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Interpretation of surrogate endpoints in the era of the 21st Century Cures Act. BMJ. 2016 Dec 30; 355:i6286.
Score: 0.031
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Evaluation of a potential clinical interaction between ceftriaxone and calcium. Antimicrob Agents Chemother. 2010 Apr; 54(4):1534-40.
Score: 0.019
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Hepatotoxicity associated with long- versus short-course HIV-prophylactic nevirapine use: a systematic review and meta-analysis from the Research on Adverse Drug events And Reports (RADAR) project. Drug Saf. 2009; 32(2):147-58.
Score: 0.018
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Gemtuzumab ozogamicin-associated sinusoidal obstructive syndrome (SOS): an overview from the research on adverse drug events and reports (RADAR) project. Leuk Res. 2007 May; 31(5):599-604.
Score: 0.015