Process-induced toxicants in food: an overview on structures, formation pathways, sensory properties, safety and health implications by Adel Mirza Alizadeh, Mansoureh Mohammadi, Fataneh Hashempour-baltork, Hedayat Hosseini, Fereidoon Shahidi

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Plain Language Summary of Publication: What is the effect of the medicine vibegron in the treatment of overactive bladder in patients with and without bladder leakage? by David Staskin, Jeffrey Frankel, Steven G. Gregg, Janet Owens-Grillo

“…The medicine vibegron was approved in 2020 by the US Food and Drug Administration (also called the FDA) to treat overactive bladder. …”
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Commercial classification of conventional polypropylene and polyester meshes for groin hernia repair: A descriptive study by Can Deniz Deveci, Stina Öberg, Jacob Rosenberg

“…MATERIALS AND METHODS: We included Food and Drug Administration (FDA)-approved conventional non-coated flat meshes made of polypropylene or polyester. …”
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Systemic adverse drug events to topical prostaglandin analogs for treating glaucoma: a retrospective focused pharmacovigilance study by Kannan Sridharan

“…This study investigates the systemic ADEs associated with topical prostaglandin analogs using the United States Food and Drug Administration (USFDA) Adverse Drug Event Reporting System (AERS) database. …”
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Metformin: A Potential Drug for COVID-19 by Anjali Devi Bettadapura Shankara Rao, Sujatha Puttalingaiah, Ananth B Koushik, Jadeppa Gowda

“…The drug is already approved by the US Food and Drug Administration (FDA) and thus repurposing it in COVID-19 patients may be beneficial. …”
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Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process by Breanne Stewart, Pirkko Lepola, Gunter F. Egger, Fahimeda Ali, Albert J. Allen, Albert J. Allen, Alysha K. Croker, Andrew J. Davidson, Pamela Dicks, Saul N. Faust, Saul N. Faust, Dionna Green, Collin Hovinga, Collin Hovinga, Agnes V. Klein, Robyn Langham, Hidefumi Nakamura, Laura Pioppo, Shiva Ramroop, Michiyo Sakiyama, Isabel Sanchez Vigil de la Villa, Junko Sato, Donna L. Snyder, Mark A. Turner, Mark A. Turner, Sarah Zaidi, Kanecia Zimmerman, Kanecia Zimmerman, Thierry Lacaze-Masmonteil

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Early and Midterm Outcomes of Percutaneous Arteriovenous Fistula Creation by Ahmed Kamel Abdel Aal, Juri Bassuner, Husameddin El Khudari, Reema F. Alrasheed, Shahroz Aziz, Mohamed Shahin, Ammar Almehmi, Bridget Kowalczyk

“…Currently, there are two Food and Drug Administration (FDA) approved systems, namely WavelinQ and Ellipsys. …”
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Interaction between dipeptidyl-peptidase-4 inhibitors and drugs acting on renin angiotensin aldosterone system for the risk of angioedema: a pharmacovigilance assessment using disp... by Kannan Sridharan, Gowri Sivaramakrishnan

“…Methods We conducted a comprehensive pharmacovigilance analysis using the United States Food and Drug Administration Adverse Event Reporting System (USFDA AERS) database. …”
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Progression-free survival as a surrogate endpoint in myeloma clinical trials: an evolving paradigm by Charlotte Pawlyn, Fredrik H. Schjesvold, David A. Cairns, L. J. Wei, Faith Davies, Omar Nadeem, Haifaa Abdulhaq, Maria-Victoria Mateos, Jacob Laubach, Katja Weisel, Heinz Ludwig, S. Vincent Rajkumar, Pieter Sonneveld, Graham Jackson, Gareth Morgan, Paul G. Richardson

“…Surrogate endpoints of OS, such as progression-free survival (PFS) and response to treatment, have contributed to approval decisions by the Food and Drug Administration (FDA) and European Medicines Agency as endpoints demonstrating clinical benefit, and the FDA has recently supported the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma. …”
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Knowledge, Attitude, Practice, and Barriers of Adverse Drug Reaction Reporting Among Healthcare Professionals in Timor‐Leste: A Cross‐Sectional Survey by Juanina daCosta, Wichit Nosoongnoen, Watcharee Rungapiromnan, Pramote Tragulpiankit

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A real-world pharmacovigilance analysis of potential ototoxicity associated with sacubitril/valsartan based on FDA Adverse Event Reporting System (FAERS) by Ning Wang, Haijun Wang, Ying Chen, Yanfeng Wang

“…Disproportionality analysis was performed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2015 to 2023. …”
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Spray drying of saffron extract-loaded coacervates by carboxymethyl cellulose/maltodextrin/saffron petal anthocyanins by Hamid Rajabi, Samineh Sedaghati, Hamidreza Farajnezhad, Seid Mahdi Jafari

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The importance of tissue science and valve design in relation to durability and hemodynamics of the DurAVR aortic heart valve by William M. L. Neethling, Guenther Forster, Christopher Meduri, Bart Meuris, Anita W. Asgar, Stephanie Sellers, João L. Cavalcante, Vinayak Bapat, Michael Reardon

“…IntroductionClinical evidence highlighting the efficacy and safety of transcatheter aortic valve replacement (TAVR) and the 2019 Food and Drug Administration (FDA) approval for TAVR in low-risk (younger) patients has created a demand for durable and long-lasting bioprosthetic heart valve (BHV) leaflet materials. …”
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Time to pregnancy recognition among users of an FDA-cleared fertility application by Agathe van Lamsweerde, Jack T. Pearson, Rachel Urrutia, Kristina Gemzell-Danielsson, Helena Kopp Kallner, Anita Nelson, Eleonora Benhar, Carlotta Favaro, Elina Berglund Scherwitzl, Raoul Scherwitzl

“…Timely pregnancy recognition can help individuals in health and pregnancy management, reducing maternal and foetal risk and costs, whilst increasing treatment options, availability, and cost.Methods This dataset contained 23,728 pregnancies (conceived between June 2018 and December 2022) from 20,429 participants using a Food and Drug Administration (FDA) cleared fertility app in the United States. …”
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Evaluation of reporting trends in the MAUDE Database: 1991 to 2022 by Meital Mishali, Nadav Sheffer, Oren Mishali, Maya Negev

“…Adverse event reporting for medical devices is critical for risk mitigation. The Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database serves as a key tool for post-market surveillance, receiving reports from various sources. …”
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Recent Advances in Indocyanine Green-Based Probes for Second Near-Infrared Fluorescence Imaging and Therapy by Dehong Hu, Menglei Zha, Hairong Zheng, Duyang Gao, Zonghai Sheng

“…Indocyanine green (ICG), a US Food and Drug Administration-approved NIR fluorophore, has long been used in clinical applications, including blood vessel angiography, vascular perfusion monitoring, and tumor detection. …”
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Measles neutralising antibody levels in patients receiving intravenous immunoglobulin treatment - a sub-analysis of a randomized, cross-over bioequivalence trial. by Vatsala Rajendram, Martyn Paddick, John More

“…Each batch of intravenous immunoglobulin is required by the Food and Drug Administration to contain threshold levels of measles neutralising antibodies. …”
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Safety assessment of rosuvastatin-fenofibrate combination in the treatment of hyperlipidemia based on FDA’s adverse event reporting system database by Qun Li, Wenya Shan, Saiwei Wu

“…In this study, we analyzed the safety signals of rosuvastatin-fenofibrate combination by assessing the publicly available US Food and Drug Administration Adverse Event Reporting System (FAERS), so as to provide a reference for rational clinical use of rosuvastatin and fenofibrate, and reduce the occurrence of related AEs.MethodsReports to the FAERS from 1 January 2004 to 19 March 2020 were analyzed. …”
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A Systematic Literature Review and Indirect Treatment Comparison of Efficacy of Repository Corticotropin Injection versus Synthetic Adrenocorticotropic Hormone for Infantile Spasms by Michael S. Duchowny, Ishveen Chopra, John Niewoehner, George J. Wan, Beth Devine

“…RCI is a naturally-sourced complex mixture of purified ACTH analogs and other pituitary peptides approved by the United States Food and Drug Administration as a monotherapy for the treatment of infantile spasms. …”
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Six events that shaped antibody approvals in oncology by Suman Paul, Suman Paul, Shibin Zhou, Shibin Zhou

“…A little over twenty-five years ago, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) approved the chimeric antibody rituximab which fundamentally altered the landscape of anti-cancer drugs. …”
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