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https://www.readbyqxmd.com/read/28921643/bridging-adult-experience-to-pediatrics-in-oncology-drug-development
#1
Ruby Leong, Hong Zhao, Gregory Reaman, Qi Liu, Yaning Wang, Clinton F Stewart, Gilbert Burckart
Pediatric drug development in the United States has grown under the current regulations made permanent by the Food and Drug Administration Safety and Innovation Act of 2012. Over 1200 pediatric studies have now been submitted to the US FDA, but there is still a high rate of failure to obtain pediatric labeling for the indication pursued. Pediatric oncology represents special problems in that the disease is most often dissimilar to any cancer found in the adult population. Therefore, the development of drug dosing in pediatric oncology patients represents a special challenge...
October 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28919663/methods-for-scalar-on-function-regression
#2
Philip T Reiss, Jeff Goldsmith, Han Lin Shang, R Todd Ogden
Recent years have seen an explosion of activity in the field of functional data analysis (FDA), in which curves, spectra, images, etc. are considered as basic functional data units. A central problem in FDA is how to fit regression models with scalar responses and functional data points as predictors. We review some of the main approaches to this problem, categorizing the basic model types as linear, nonlinear and nonparametric. We discuss publicly available software packages, and illustrate some of the procedures by application to a functional magnetic resonance imaging dataset...
August 2017: International Statistical Review, Revue Internationale de Statistique
https://www.readbyqxmd.com/read/28914189/a-hopeful-prospect-of-riociguat-as-a-soluble-guanylate-cyclase-stimulator-for-management-of-pressure-ulcers
#3
Soha Azadi, Hajar Ashrafi, Amir Azadi
Pressure ulcer remains as a common problem, especially developed in disabled patients and hence, subjected to continuous pressure for prolonged periods of time. Most of the studies investigating the preventive and therapeutic approaches have focused on wound cleansing, dressing and supportive strategies , as well as pharmacological therapy including zinc sulphate, vitamin A or phenytoin. Despite such efforts, pressure ulcer continues to impair the life quality and expectancy. Thus involving in the paradigm shift in biomedical studies, the recent ones focus on biological signaling pathways involving nitric oxide (NO)- soluble guanylatecyclase (sGC)- cyclic guanosine monophosphate (cGMP) contributing in vasodilation, reperfusion and oxygen delivery...
September 15, 2017: Current Drug Discovery Technologies
https://www.readbyqxmd.com/read/28910299/access-to-benznidazole-for-chagas-disease-in-the-united-states-cautious-optimism
#4
Jonathan D Alpern, Rogelio Lopez-Velez, William M Stauffer
Drugs for neglected tropical diseases (NTD) are being excessively priced in the United States. Benznidazole, the first-line drug for Chagas disease, may become approved by the Food and Drug Administration (FDA) and manufactured by a private company in the US, thus placing it at risk of similar pricing. Chagas disease is an NTD caused by Trypanosoma cruzi; it is endemic to Latin America, infecting 8 million individuals. Human migration has changed the epidemiology causing nonendemic countries to face increased challenges in diagnosing and managing patients with Chagas disease...
September 2017: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/28895231/software-related-recalls-of-health-information-technology-and-other-medical-devices-implications-for-fda-regulation-of-digital-health
#5
Jay G Ronquillo, Diana M Zuckerman
Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market...
September 2017: Milbank Quarterly
https://www.readbyqxmd.com/read/28893276/imipramine-blocks-acute-silicosis-in-a-mouse-model
#6
Rupa Biswas, Kevin L Trout, Forrest Jessop, Jack R Harkema, Andrij Holian
BACKGROUND: Inhalation of crystalline silica is associated with pulmonary inflammation and silicosis. Although silicosis remains a prevalent health problem throughout the world, effective treatment choices are limited. Imipramine (IMP) is a FDA approved tricyclic antidepressant drug with lysosomotropic characteristics. The aim of this study was to evaluate the potential for IMP to reduce silicosis and block phagolysosome membrane permeabilization. METHODS: C57BL/6 alveolar macrophages (AM) exposed to crystalline silica ± IMP in vitro were assessed for IL-1β release, cytotoxicity, particle uptake, lysosomal stability, and acid sphingomyelinase activity...
September 11, 2017: Particle and Fibre Toxicology
https://www.readbyqxmd.com/read/28845371/predicting-drug-recalls-from-internet-search-engine-queries
#7
Elad Yom-Tov
Batches of pharmaceuticals are sometimes recalled from the market when a safety issue or a defect is detected in specific production runs of a drug. Such problems are usually detected when patients or healthcare providers report abnormalities to medical authorities. Here, we test the hypothesis that defective production lots can be detected earlier by monitoring queries to Internet search engines. We extracted queries from the USA to the Bing search engine, which mentioned one of the 5195 pharmaceutical drugs during 2015 and all recall notifications issued by the Food and Drug Administration (FDA) during that year...
2017: IEEE Journal of Translational Engineering in Health and Medicine
https://www.readbyqxmd.com/read/28838285/a-review-on-golimumab-in-the-treatment-of-psoriatic-arthritis
#8
Maria Urdaneta, Hannah Jethwa, Reshma Sultan, Sonya Abraham
Psoriatic arthritis (PsA) causes inflammation in and around the joints and usually affects people who already have psoriasis. However, some patients develop the joint problems before the psoriasis. Currently, there are five anti-TNF-α agents licensed for use in patients with PsA: adalimumab, certolizumab pegol, etanercept, golimumab and infliximab. Golimumab, a human monoclonal antibody, has been approved by the US FDA for the treatment of PsA and is targeted against the pro-inflammatory molecule TNF-α. The Phase III GO-REVEAL study confirmed this drug was well tolerated and showed significant improvement in disease activity compared with placebo...
August 25, 2017: Immunotherapy
https://www.readbyqxmd.com/read/28833803/important-statistical-considerations-in-the-evaluation-of-post-market-studies-to-assess-whether-opioids-with-abuse-deterrent-properties-result-in-reduced-abuse-in-the-community
#9
Kunthel By, Jana K McAninch, Stephine L Keeton, Alex Secora, Cynthia J Kornegay, Catherine S Hwang, Thomas Ly, Mark S Levenson
PURPOSE: Abuse, misuse, addiction, overdose, and death associated with non-medical use of prescription opioids have become a serious public health concern. Reformulation of these products with abuse-deterrent properties is one approach for addressing this problem. FDA has approved several extended-release opioid analgesics with abuse-deterrent labeling, the bases of which come from pre-market studies. As all opioid analgesics must be capable of delivering the opioid in order to reduce pain, abuse-deterrent properties do not prevent abuse, nor do pre-market evaluations ensure that there will be reduced abuse in the community...
August 23, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815334/clinical-characteristics-of-patient-selection-and-imaging-predictors-of-outcome-in-solid-tumors-treated-with-checkpoint-inhibitors
#10
REVIEW
Sabrina Rossi, Luca Toschi, Angelo Castello, Fabio Grizzi, Luigi Mansi, Egesta Lopci
The rapidly evolving knowledge on tumor immunology and the continuous implementation of immunotherapy in cancer have recently led to the FDA and EMA approval of several checkpoint inhibitors as immunotherapic agents in clinical practice. Anti-CTLA-4, anti-PD-1, and anti-PDL-1 antibodies are becoming standard of care in advanced melanoma, as well as in relapsed or metastatic lung and kidney cancer, demonstrating higher and longer response compared to standard chemotherapy. These encouraging results have fostered the evaluation of these antibodies either alone or in combination with other therapies in several dozen clinical trials for the treatment of multiple tumor types...
August 16, 2017: European Journal of Nuclear Medicine and Molecular Imaging
https://www.readbyqxmd.com/read/28796163/hypertension-caused-by-lenvatinib-and-everolimus-in-the-treatment-of-metastatic-renal-cell-carcinoma
#11
REVIEW
Mathias Alrø Fichtner Bendtsen, Daniela Grimm, Johann Bauer, Markus Wehland, Petra Wise, Nils E Magnusson, Manfred Infanger, Marcus Krüger
Multikinase inhibitors (MKI) and mammalian target of rapamycin (mTOR) inhibitors prolong progression-free (PFS) and overall survival (OS) in the treatment of metastatic renal cell carcinoma (mRCC) by reducing angiogenesis and tumor growth. In this regard, the MKI lenvatinib and the mTOR inhibitor everolimus proved effective when applied alone, but more effective when they were administered combined. Recently, both drugs were included in clinical trials, resulting in international clinical guidelines for the treatment of mRCC...
August 10, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28794970/agreement-of-msmetrix-with-established-methods-for-measuring-cross-sectional-and-longitudinal-brain-atrophy
#12
Martijn D Steenwijk, Houshang Amiri, Menno M Schoonheim, Alexandra de Sitter, Frederik Barkhof, Petra J W Pouwels, Hugo Vrenken
INTRODUCTION: Despite the recognized importance of atrophy in multiple sclerosis (MS), methods for its quantification have been mostly restricted to the research domain. Recently, a CE labelled and FDA approved MS-specific atrophy quantification method, MSmetrix, has become commercially available. Here we perform a validation of MSmetrix against established methods in simulated and in vivo MRI data. METHODS: Whole-brain and gray matter (GM) volume were measured with the cross-sectional pipeline of MSmetrix and compared to the outcomes of FreeSurfer (cross-sectional pipeline), SIENAX and SPM...
2017: NeuroImage: Clinical
https://www.readbyqxmd.com/read/28777177/chronic-insomnia-disorder
#13
Alon Y Avidan, David N Neubauer
PURPOSE OF REVIEW: Neurologists, along with all health care providers, commonly encounter patients with insomnia, which is a condition that impacts patients' underlying neurologic conditions in a bidirectional manner. While chronic insomnia is one of the most common sleep disturbances, only a small proportion of individuals with this condition discuss their sleep problems with their providers. When insomnia is described, it is more often in relationship to another medical problem, as opposed to an independent condition...
August 2017: Continuum: Lifelong Learning in Neurology
https://www.readbyqxmd.com/read/28774438/individualized-drug-dosing-using-rbf-galerkin-method-case-of-anemia-management-in-chronic-kidney-disease
#14
Hossein Mirinejad, Adam E Gaweda, Michael E Brier, Jacek M Zurada, Tamer Inanc
BACKGROUND AND OBJECTIVE: Anemia is a common comorbidity in patients with chronic kidney disease (CKD) and is frequently associated with decreased physical component of quality of life, as well as adverse cardiovascular events. Current treatment methods for renal anemia are mostly population-based approaches treating individual patients with a one-size-fits-all model. However, FDA recommendations stipulate individualized anemia treatment with precise control of the hemoglobin concentration and minimal drug utilization...
September 2017: Computer Methods and Programs in Biomedicine
https://www.readbyqxmd.com/read/28729910/drug-induced-gingival-hyperplasia-a-retrospective-study-using-spontaneous-reporting-system-databases
#15
Haruna Hatahira, Junko Abe, Yuuki Hane, Toshinobu Matsui, Sayaka Sasaoka, Yumi Motooka, Shiori Hasegawa, Akiho Fukuda, Misa Naganuma, Tomofumi Ohmori, Yasutomi Kinosada, Mitsuhiro Nakamura
BACKGROUND: Drug-induced gingival hyperplasia (DIGH) causes problems with chewing, aesthetics, and pronunciation, and leads to the deterioration of the patient's quality of life (QOL). Thus, the aim of this study was to evaluate the incidence of DIGH using spontaneous reporting system (SRS) databases. METHODS: We analyzed reports of DIGH from SRS databases and calculated the reporting odds ratios (RORs) of suspected drugs (immunosuppressants, calcium channel blockers, and anticonvulsants)...
2017: Journal of Pharmaceutical Health Care and Sciences
https://www.readbyqxmd.com/read/28724335/exploring-the-potential-for-using-drug-indications-to-prevent-look-alike-and-sound-alike-drug-errors
#16
Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Saad Alqahtani, Gordon Schiff
BACKGROUND: Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs. RESEARCH DESIGN AND METHODS: We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities...
July 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28711892/3-d-bioprinting-law-regulation-perspectives
#17
Vitalii Pashkov, Andrii Harkusha
INTRODUCTION: Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts...
2017: Wiadomości Lekarskie: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/28705006/best-practices-for-the-treatment-of-metastatic-pancreatic-adenocarcinoma-the-therapeutic-landscape-in-2017
#18
Pelin Cinar, Andrew H Ko
The vast majority of patients diagnosed with pancreatic adenocarcinoma have inoperable, most commonly metastatic, disease at the time of initial presentation, at which point systemic therapy becomes the mainstay of treatment. Although survival rates remain very poor in this clinical setting, patients currently have a greater number of therapeutic options available to them than ever before, and consequently individuals are more frequently able to be sequenced through multiple lines of treatment. In this review, we will provide an overview of the current treatment landscape for metastatic pancreatic cancer in 2017, focusing on best practices and the various factors that should be considered in selecting the most appropriate regimen for a given individual...
June 2017: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/28675919/composite-and-multicomponent-end-points-in-clinical-trials
#19
Abdul J Sankoh, Haihong Li, Ralph B D'Agostino
In January 2017, the FDA released the draft guidance to industry on multiple end points in clinical trials. A class of multiplicity problems arise from the testing of individual or subset of components of a composite or multicomponent end point. This commentary attempts to further clarify these problems. Discussions include general consideration on the use of the composite and multicomponent end points, situations when multiplicity adjustments are needed, and the relevant multiple testing methods. Copyright © 2017 John Wiley & Sons, Ltd...
July 4, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28673647/regulation-and-device-development-tips-for-optimizing-your-experience-with-the-food-and-drug-administration
#20
Steven S Brooks
Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices...
June 2017: Techniques in Vascular and Interventional Radiology
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