Should the Food and Drug Administration Limit Placebo-Controlled Trials? by Max Goodman, Connor Pedersen

Subjects: “…Food and Drug Administration…”
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A Machine Learning Algorithm to Predict Medical Device Recall by the Food and Drug Administration by Victor Barbosa Slivinskis, Isabela Agi Maluli, Joshua Seth Broder

“…While the United States Food and Drug Administration (FDA) employs an adverse event reporting program (MedWatch) and database (MAUDE), other data sources and methods might have utility to identify potentially dangerous medical devices. …”
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Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database by Bojing Wang, Shu Huang, Shu Huang, Shiqi Li, Yaqi Deng, Ziyan Li, Yizhou Wang, Xiaomin Shi, Wei Zhang, Lei Shi, Xiaohong Wang, Xiaowei Tang

“…In particular, the hepatotoxicity associated with statins use has become one of the clinical concerns that require sufficient attention.MethodsIn this study, we conducted a comprehensive and detailed analysis of the hepatotoxicity of statins based on the data of the US Food and Drug Administration Adverse Event Reporting System database from the first quarter (Q1) of 2004 to the Q1 of 2024 and used Reporting Odds Ratios and Empirical Bayes Geometric Mean to mine the signal of adverse events.ResultsIn this study, hepatic disorder related seven statins all exhibited positive signals. …”
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Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017 by Bao Liu, Xingyue Zhu

“…Objective To explore the associations between the risks of postmarketing safety events of new drugs and the four expedited programmes of priority review, accelerated approval, fast track and breakthrough therapy established by the US Food and Drug Administration (FDA); and to investigate whether multiple uses of expedited programmes, and the combinations of expedited programmes with orphan designation, were relevant to different safety profiles.Design Cohort study.Setting USA.Participants All new drugs approved by the FDA between 1 January 2007 and 31 December 2017, followed up until 10 April 2021.Outcome measures Safety events included safety-related withdrawal, new boxed warning, drug safety communication, postapproval risk evaluation mitigation strategy and safety-related labelling changes. …”
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Exploratory disproportionality analysis of potentially drug-induced eosinophilic pneumonia using United States Food and Drug Administration adverse event reporting system by Ashwin Kamath

“…This study aims to conduct an exploratory analysis of the United States Food and Drug Administration adverse event reporting system (FAERS) database to identify previously unknown drugs that can cause EP and supplement the available evidence for known culprit drugs. …”
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Antibiotics-induced pulmonary embolism: A disproportionality analysis in Food and Drug Administration database of Adverse Event Reporting System using data mining algorithms by Pramod Kumar Adusumilli, Foujia Begum, Ankita Ashok Sangnure, Jeesa George

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Antibodies to watch in 2024 by Silvia Crescioli, Hélène Kaplon, Alicia Chenoweth, Lin Wang, Jyothsna Visweswaraiah, Janice M. Reichert

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Proton pump inhibitor leaflets: Is there information on deprescribing? by Marcus Vinícius Lopes Campos, Farah Maria Drumond Chequer, Luanna Gabriella Resende da Silva, André Oliveira Baldoni

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First, Do No Harm: Addressing AI's Challenges With Out‐of‐Distribution Data in Medicine by Chu Weng, Wesley Lin, Sherry Dong, Qi Liu, Hanrui Zhang

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ATP-Binding Cassette Genes Genotype and Expression: A Potential Association with Pancreatic Cancer Development and Chemoresistance? by Li Pang, Beverly Word, Joshua Xu, Honggang Wang, George Hammons, Shiew-Mei Huang, Beverly Lyn-Cook

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A novel proficiency test to assess the animal diagnostic investigation process in identifying an unknown toxicant by Andriy Tkachenko, Yang Chen, Marissa Petrey, Scott Fritz, Tim Walsh, David Rotstein, Megan R. Miller, Bruce Williams, Michael Dark, Matthew Kmet, Ravinder Reddy, Gregory Tyson, Sarah M. Nemser

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Acute pain pathways: protocol for a prospective cohort study by Christine Lee, Joseph S Ross, Molly Moore Jeffery, Nilay D Shah, David B Page, Nancy Chang, Fernanda Bellolio, Sam Torbati, Jessica D Ritchie, Gregg H Gilbert, Lindsay Emanuel, Mitra Ahadpour, Summer Allen, Richardae Araojo, Laura Ciaccio, Jonathan Fillmore, Patricia Koussis, Heather Lipkind, Celeste Mallama, Tamra Meyer, Megan Moncur, Teryl Nuckols, Michael A Pacanowski, Elektra Papadopoulos, Mat Soukup, Christopher O St. Clair, Stephen Tamang, Douglas W Wallace, Yueqin Zhao, Rebekah Heckmann

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A headspace-gas chromatography method for isopropanol determination in warfarin sodium products as a measure of drug crystallinity by Rahman Ziyaur, Akhtar Sohail, Siddiqui Akhtar, Ciavarella Anthony B., Nguyenpho Agnes, Faustino Patrick J., Khan Mansoor A.

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Anesthetic-Induced Oxidative Stress and Potential Protection by Cheng Wang, Xuan Zhang, Fang Liu, Merle G. Paule, William Slikker, Jr.

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Corrigendum to “Cardiovascular disease outcomes among established cigar users 40 years and older: Findings from the population assessment of tobacco and health (PATH) study, Waves... by Eva Sharma, Zhiqun Tang, Kristin Lauten, Marushka L. Silveira, Cristine D. Delnevo, Kathryn C. Edwards, Daniela Marshall, Diann E. Gaalema, Izabella Zandberg, Bria Graham-Glover, Derick L. Rivers, Omoye E. Imoisili, Kirstie Neal, Raymond Niaura, Maansi Bansal-Travers, Andrew Hyland, K. Michael Cummings

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Quantitative Multiparameter Evaluation of Vacuoles in Intraocular Lenses Employing a High-Magnification Digital Microscopy Method by Vincent Spiezio, Bennett N. Walker, Don Calogero, Ilko K. Ilev

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Evaluating Normalization Methods for Robust Spectral Performance Assessments of Hyperspectral Imaging Cameras by Siavash Mazdeyasna, Mohammed Shahriar Arefin, Andrew Fales, Silas J. Leavesley, T. Joshua Pfefer, Quanzeng Wang

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Delineating Molecular Mechanisms of Squamous Tissue Homeostasis and Neoplasia: Focus on p63 by Kathryn E. King, Linan Ha, Tura Camilli, Wendy C. Weinberg

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<i>Salmonella enterica</i> serovar Schwarzengrund: Distribution, Virulence, and Antimicrobial Resistance by Monique A. Felix, Jing Han, Bijay K. Khajanchi, Yasser M. Sanad, Shaohua Zhao, Steven L. Foley

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A comprehensive method on black-legged tick larvae and nymph feeding on mice to study Lyme disease transmission and acquisition by Aaron Scholl, Bingjie Li, John Dennis, Sandip De

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