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FDA Drug Classification

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https://www.readbyqxmd.com/read/28616097/updated-report-on-tools-to-measure-outcomes-of-clinical-trials-in-fragile-x-syndrome
#1
REVIEW
Dejan B Budimirovic, Elizabeth Berry-Kravis, Craig A Erickson, Scott S Hall, David Hessl, Allan L Reiss, Margaret K King, Leonard Abbeduto, Walter E Kaufmann
OBJECTIVE: Fragile X syndrome (FXS) has been the neurodevelopmental disorder with the most active translation of preclinical breakthroughs into clinical trials. This process has led to a critical assessment of outcome measures, which resulted in a comprehensive review published in 2013. Nevertheless, the disappointing outcome of several recent phase III drug trials in FXS, and parallel efforts at evaluating behavioral endpoints for trials in autism spectrum disorder (ASD), has emphasized the need for re-assessing outcome measures and revising recommendations for FXS...
2017: Journal of Neurodevelopmental Disorders
https://www.readbyqxmd.com/read/28593504/an-algorithm-to-identify-generic-drugs-in-the-fda-adverse-event-reporting-system
#2
Geetha Iyer, Sathiya Priya Marimuthu, Jodi B Segal, Sonal Singh
INTRODUCTION: Although generic drugs constitute approximately 88% of drugs prescribed in the US, there are no reliable methods to identify generic drugs in the US FDA Adverse Event Reporting System (FAERS). OBJECTIVE: The aim of this study was to develop an algorithm for identifying generic drugs in the FAERS. DATA SOURCE: We used 1237 adverse event reports for tamsulosin, levothyroxine, and amphetamine/dextroamphetamine from the publicly available FAERS from 2011-2013, and 277 source case narratives obtained from the FDA...
June 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28588760/the-impact-of-database-restriction-on-pharmacovigilance-signal-detection-of-selected-cancer-therapies
#3
Manfred Hauben, Eric Hung, Jennifer Wood, Amit Soitkar, Daniel Reshef
BACKGROUND: The aim of this study was to investigate whether database restriction can improve oncology drug pharmacovigilance signal detection performance. METHODS: We used spontaneous adverse event (AE) reports in the United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Positive control (PC) drug medical concept (DMC) pairs were selected from safety information not included in the product's first label but subsequently added as label changes...
May 2017: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/28583106/prescription-drug-use-during-pregnancy-in-southern-tigray-region-north-ethiopia
#4
Fantahun Molla, Admassu Assen, Solomon Abrha, Birhanetensay Masresha, Arega Gashaw, Abrham Wondimu, Yared Belete, Wondim Melkam
BACKGROUND: Judicious utilization of drugs rescues the fetus from the harmful effects while treating the health problems of the pregnant women. This study aimed at evaluating drug utilization pattern and its associated factors among pregnant women in Southern Tigray, Ethiopia. METHOD: Institution based cross-sectional study was conducted among 647 pregnant women who had been attending obstetrics-gynecology and antenatal care units in different health facilities of Southern Tigray region...
June 5, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28555158/the-nonradiographic-axial-spondyloarthritis-the-radiographic-axial-spondyloarthritis-and-ankylosing-spondylitis-the-tangled-skein-of-rheumatology
#5
REVIEW
Anand N Malaviya, Roopa Rawat, Neha Agrawal, Nilesh S Patil
Since 1984 the diagnosis of ankylosing spondylitis (AS) has been based upon the modified New York (mNY) criteria with mandatory presence of radiographic sacroiliitis, without which the diagnosis is not tenable. However, it may take years or decades for radiographic sacroiliitis to develop delaying the diagnosis for long periods. It did not matter in the past because no effective treatment was available. However, with the availability of a highly effective treatment, namely, tumour necrosis factor-α inhibitors (TNFi), the issue of early diagnosis of AS acquired an urgency...
2017: International Journal of Rheumatology
https://www.readbyqxmd.com/read/28521373/paediatric-medicines-regulatory-and-scientific-issues
#6
Chrysa Daousani, Vangelis D Karalis
In the past, dosage regimens authorized for adults were extrapolated to children relying mainly on empirical dosage adjustments. However, children are not small adults, but a distinct and heterogeneous group in terms of physiology, disease occurrence, pharmacokinetics, pharmacodynamics and also psychological, cognitive, and behavioral aspects. Even though it would be helpful to know the physiological changes and the special drug treatment needs in children, this task could not be performed due to ethical reasons...
May 18, 2017: Drug Research
https://www.readbyqxmd.com/read/28457128/matrix-extension-and-multilaboratory-validation-of-arsenic-speciation-method-eam-%C3%A2-4-10-to-include-wine
#7
Courtney K Tanabe, Helene Hopfer, Susan E Ebeler, Jenny Nelson, Sean D Conklin, Kevin M Kubachka, Robert A Wilson
A multilaboratory validation (MLV) was performed to extend the U.S. Food and Drug Administration's (FDA) analytical method Elemental Analysis Manual (EAM) §4.10, High Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Determination of Four Arsenic Species in Fruit Juice, to include wine. Several method modifications were examined to optimize the method for the analysis of dimethylarsinic acid, monomethylarsonic acid, arsenate (AsV), and arsenite (AsIII) in various wine matrices with a range of ethanol concentrations by liquid chromatography-inductively coupled plasma-mass spectrometry...
May 24, 2017: Journal of Agricultural and Food Chemistry
https://www.readbyqxmd.com/read/28359076/general-guidelines-for-quality-assurance-of-immunohistochemistry-in-a-mohs-lab
#8
REVIEW
Carrie G Kinas, Bryan T Carroll
BACKGROUND: The adoption of recently created protocols introduces Mohs laboratories to the principles of immunohistochemistry (IHC) performance validation and clinical laboratory regulations that are unique to these evolving technologies. OBJECTIVE: To review Food and Drug Administration (FDA) IHC reagent classifications, IHC validation protocols, and quality assurance (QA) procedures and documentation needed in conjunction with IHC test guidelines. METHODS: A focused review of IHC reagent classifications and guidelines in clinical testing laboratories was conducted using PubMed and FDA source documents...
April 2017: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
https://www.readbyqxmd.com/read/28355048/medical-devices-neurological-devices-classification-of-the-vibratory-counter-stimulation-device-final-order
#9
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the vibratory counter-stimulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the vibratory counter-stimulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
March 14, 2017: Federal Register
https://www.readbyqxmd.com/read/28355047/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-high-throughput-genomic-sequence-analyzer-for-clinical-use-final-order
#10
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the high throughput genomic sequence analyzer for clinical use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the high throughput genomic sequence analyzer for clinical use device. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device...
March 14, 2017: Federal Register
https://www.readbyqxmd.com/read/28355046/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-continuous-glucose-monitor-secondary-display-final-order
#11
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the continuous glucose monitor secondary display into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the continuous glucose monitor secondary display’s classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
March 14, 2017: Federal Register
https://www.readbyqxmd.com/read/28322140/applications-and-risks-of-nanomaterials-used-in-regenerative-medicine-delivery-systems-theranostics-and-therapy
#12
REVIEW
Estefany I Medina-Reyes, Danae Garcia-Viacobo, Franklin A Carrero-Martinez, Yolanda Irasema Chirino
Recent advances in nanotechnology have transformed the biomedicine field, in which the use of engineered nanomaterials (ENMs) has provided the foundation for novel applications. For this reason, the number of ENMs has increased rapidly, and here we provide a classification of ENMs based on chemical composition and biomedical applications, which include regenerative medicine, delivery systems, theranostics, and therapy. These have been identified as the most advanced and promising areas for further studies with humans...
2017: Critical Reviews in Therapeutic Drug Carrier Systems
https://www.readbyqxmd.com/read/28292487/a-review-of-patient-reported-outcome-labeling-in-the-united-states-2011-2015
#13
COMPARATIVE STUDY
Ari Gnanasakthy, Margaret Mordin, Emily Evans, Lynda Doward, Carla DeMuro
BACKGROUND: A review of new drug approvals (NDAs) by the Food and Drug Administration (FDA) for 2006 to 2010 showed that 24.1% of new drugs had patient-reported outcome (PRO) labeling. OBJECTIVES: To review PRO labeling for NDAs for 2011 to 2015 and to compare key findings reported previously. METHODS: A review of the FDA drug approval reports for NDAs was conducted using the FDA Web site to determine the number of NDAs for the period 2011 to 2015...
March 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28281194/development-considerations-for-nanocrystal-drug-products
#14
Mei-Ling Chen, Mathew John, Sau L Lee, Katherine M Tyner
Nanocrystal technology has emerged as a valuable tool for facilitating the delivery of poorly water-soluble active pharmaceutical ingredients (APIs) and enhancing API bioavailability. To date, the US Food and Drug Administration (FDA) has received over 80 applications for drug products containing nanocrystals. These products can be delivered by different routes of administration and are used in a variety of therapeutic areas. To aid in identifying key developmental considerations for these products, a retrospective analysis was performed on the submissions received by the FDA to date...
March 9, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28257576/evaluation-of-dili-predictive-hypotheses-in-early-drug-development
#15
Rosa Chan, Leslie Z Benet
Drug-induced liver injury (DILI) is a leading cause of drug failure in clinical trials and a major reason for drug withdrawals. DILI has been shown to be dependent on both daily dose and extent of hepatic metabolism. Yet, early in drug development daily dose is unknown. Here, we perform a comprehensive analysis of the published hypotheses that attempt to predict DILI, including a new analysis of the Biopharmaceutics Drug Disposition Classification System (BDDCS) in evaluating the severity of DILI warnings in drug labels approved by the FDA and the withdrawal status due to adverse drug reactions (ADRs)...
April 17, 2017: Chemical Research in Toxicology
https://www.readbyqxmd.com/read/28241745/drug-voyager-a-computational-platform-for-exploring-unintended-drug-action
#16
Min Oh, Jaegyoon Ahn, Taekeon Lee, Giup Jang, Chihyun Park, Youngmi Yoon
BACKGROUND: The dominant paradigm in understanding drug action focuses on the intended therapeutic effects and frequent adverse reactions. However, this approach may limit opportunities to grasp unintended drug actions, which can open up channels to repurpose existing drugs and identify rare adverse drug reactions. Advances in systems biology can be exploited to comprehensively understand pharmacodynamic actions, although proper frameworks to represent drug actions are still lacking. RESULTS: We suggest a novel platform to construct a drug-specific pathway in which a molecular-level mechanism of action is formulated based on pharmacologic, pharmacogenomic, transcriptomic, and phenotypic data related to drug response ( http://databio...
February 28, 2017: BMC Bioinformatics
https://www.readbyqxmd.com/read/28211644/healthcare-professionals-and-pharmacovigilance-of-pediatric-adverse-drug-reactions-a-5-year-analysis-of-adverse-events-reporting-system-database-of-the-food-and-drug-administration
#17
Caterina Bigi, Marco Tuccori, Guido Bocci
BACKGROUND: To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. METHODS: Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis...
February 17, 2017: Minerva Pediatrica
https://www.readbyqxmd.com/read/28102980/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for-use-directly-with-clinical-specimens-final-order
#18
(no author information available yet)
The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.
January 12, 2017: Federal Register
https://www.readbyqxmd.com/read/28068049/medical-devices-neurological-devices-classification-of-the-neurovascular-mechanical-thrombectomy-device-for-acute-ischemic-stroke-treatment-final-order
#19
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device...
December 23, 2016: Federal Register
https://www.readbyqxmd.com/read/28030887/general-hospital-and-personal-use-devices-renaming-of-pediatric-hospital-bed-classification-and-designation-of-special-controls-for-pediatric-medical-crib-classification-of-medical-bassinet-final-rule
#20
(no author information available yet)
The Food and Drug Administration (FDA) is issuing a final rule to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also establishing a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. In addition, this rule continues to allow both devices to be exempt from premarket notification and use of the device in traditional health care settings and permits prescription use of pediatric medical cribs and bassinets outside of traditional health care settings...
December 19, 2016: Federal Register
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