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Bennett, Charles
One or more keywords matched the following items that are connected to Bennett, Charles
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Concept United States Food and Drug Administration
Academic Article Effects of the US Food and Drug Administration Boxed Warning of Erythropoietin-Stimulating Agents on Utilization and Adverse Outcome.
Academic Article Reply to A.M. Zeidan et al.
Academic Article Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.
Academic Article 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.
Academic Article Clopidogrel-associated TTP: an update of pharmacovigilance efforts conducted by independent researchers, pharmaceutical suppliers, and the Food and Drug Administration.
Academic Article Serious adverse cutaneous and hepatic toxicities associated with nevirapine use by non-HIV-infected individuals.
Academic Article 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.
Academic Article Gemtuzumab ozogamicin-associated sinusoidal obstructive syndrome (SOS): an overview from the research on adverse drug events and reports (RADAR) project.
Academic Article Adverse effects of drugs used to treat hematologic malignancies: surveillance efforts from the research on adverse drug events and reports project.
Academic Article Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers.
Academic Article Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw.
Academic Article 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.
Academic Article Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?
Academic Article Evaluation of a potential clinical interaction between ceftriaxone and calcium.
Academic Article Description of anaphylactic reactions to paclitaxel and docetaxel reported to the FDA, with a focus on the role of premedication.
Academic Article 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).
Academic Article 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.
Academic Article Fluoroquinolone-associated tendon-rupture: a summary of reports in the Food and Drug Administration's adverse event reporting system.
Academic Article Evaluation of gemtuzumab ozogamycin associated sinusoidal obstructive syndrome: Findings from an academic pharmacovigilance program review and a pharmaceutical sponsored registry.
Academic Article FDA Approval of Extended-Release Oxycodone for Children With Severe Pain.
Academic Article Detection of cases of progressive multifocal leukoencephalopathy associated with new biologicals and targeted cancer therapies from the FDA's adverse event reporting system.
Academic Article Federal 340B Program Payment Scheme for Drugs Designated As Orphan Products: Congressional Clarification Needed to Close the Government-Industry Revolving Door.
Academic Article Interpretation of surrogate endpoints in the era of the 21st Century Cures Act.
Academic Article Fluoroquinolone-associated suicide.
Academic Article 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.
Academic Article Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.
Academic Article Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions.
Academic Article 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.
Academic Article Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.
Academic Article 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.
Academic Article Single-arm clinical trials that supported FDA accelerated approvals have modest effect sizes and were at high risk of bias.
Academic Article Medicare Spending on Drugs With Accelerated Approval.
Academic Article Translating Research into Health Policy: The Citizen Petition Experience with the Food and Drug Administration.
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