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FDA Drug Classification

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https://www.readbyqxmd.com/read/28753262/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-closed-loop-hysteroscopic-insufflator-with-cutter-coagulator-final-order
#1
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the closed loop hysteroscopic insufflator with cutter-coagulator 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 closed loop hysteroscopic insufflator with cutter-coagulator 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...
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28753261/medical-devices-neurological-devices-classification-of-cranial-motion-measurement-device-final-order
#2
(no author information available yet)
The Food and Drug Administration (FDA or Agency) is classifying the cranial motion measurement 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 cranial motion measurement 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.
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28753260/medical-devices-gastroenterology-urology-devices-classification-of-the-oral-removable-palatal-space-occupying-device-for-weight-management-and-or-weight-loss-final-order
#3
(no author information available yet)
The Food and Drug Administration (FDA or Agency) is classifying the oral removable palatal space occupying device for weight management and/or weight loss 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 oral removable palatal space occupying device for weight management and/or weight loss 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...
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28753259/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-cardiovascular-status-indicator-final-order
#4
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the adjunctive cardiovascular status indicator 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 adjunctive cardiovascular status indicator'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.
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28749100/medical-devices-cardiovascular-devices-classification-of-the-balloon-aortic-valvuloplasty-catheter-final-order
#5
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter 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 balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
July 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28749099/medical-devices-immunology-and-microbiology-devices-classification-of-the-assayed-quality-control-material-for-clinical-microbiology-assays-final-order
#6
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays 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 assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device...
July 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28707483/investigational-drugs-in-development-for-focal-segmental-glomerulosclerosis
#7
REVIEW
Howard Trachtman
Focal segmental glomerulosclerosis is an important cause of end stage kidney disease and is a paradigm for the study of glomerular scarring. There are no FDA approved treatments for this condition. Current therapies, assessed based on reduction in proteinuria, are generally effective in a subset of patients which suggests that FSGS is a heterogeneous group of glomerular disorders or podocytopathies that converge on a common histopathological phenotype. Areas covered: We searched for investigational drugs agents that target different pathophysiological pathways using the key words 'FSGS' and 'podocyte' in American and European clinical trial registers (clinicaltrials...
August 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28673096/review-and-analysis-of-fda-approved-drugs-using-lipid-based-formulations
#8
Ronak Savla, Jeff Browne, Vincent Plassat, Kishor M Wasan, Ellen K Wasan
Lipid-based drug delivery systems (LBDDS) are one of the most studied bioavailability enhancement technologies and are utilized in a number of U.S. Food and Drug Administration (FDA) approved drugs. While researchers have used several general rules of thumb to predict which compounds are likely to benefit from LBDDS, formulation of lipid systems is primarily an empiric endeavor. One of the challenges is that these rules of thumb focus in different areas and are used independently of each other. The Developability Classification System attempts to link physicochemical characteristics with possible formulation strategies...
July 6, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28616097/updated-report-on-tools-to-measure-outcomes-of-clinical-trials-in-fragile-x-syndrome
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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...
July 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
#15
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
#16
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
#17
(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
#18
(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
#19
(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
#20
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
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