keyword
MENU ▼
Read by QxMD icon Read
search

FDA Drug Classification

keyword
https://www.readbyqxmd.com/read/29035495/medical-devices-gastroenterology-urology-devices-classification-of-the-enzyme-packed-cartridge-final-order
#1
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the enzyme packed cartridge into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the enzyme packed cartridge's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens...
October 16, 2017: Federal Register
https://www.readbyqxmd.com/read/29035494/medical-devices-immunology-and-microbiology-devices-classification-of-the-automated-image-assessment-system-for-microbial-colonies-on-solid-culture-media-final-order
#2
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the automated image assessment system for microbial colonies on solid culture media into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated image assessment system for microbial colonies on solid culture media's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 16, 2017: Federal Register
https://www.readbyqxmd.com/read/29035493/medical-devices-immunology-and-microbiology-devices-classification-of-the-nucleic-acid-based-device-for-the-amplification-detection-and-identification-of-microbial-pathogens-directly-from-whole-blood-specimens-final-order
#3
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens' classification...
October 16, 2017: Federal Register
https://www.readbyqxmd.com/read/28990746/medical-devices-gastroenterology-urology-devices-classification-of-the-high-intensity-ultrasound-system-for-prostate-tissue-ablation-final-order
#4
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the high intensity ultrasound system for prostate tissue ablation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the high intensity ultrasound system for prostate tissue ablation’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 2, 2017: Federal Register
https://www.readbyqxmd.com/read/28947756/network-analysis-of-drug-target-interactions-a-study-on-fda-approved-new-molecular-entities-between-2000-to-2015
#5
Hui-Heng Lin, Le-Le Zhang, Ru Yan, Jin-Jian Lu, Yuanjia Hu
The U.S. Food and Drug Administration (FDA) approves new drugs every year. Drug targets are some of the most important interactive molecules for drugs, as they have a significant impact on the therapeutic effects of drugs. In this work, we thoroughly analyzed the data of small molecule drugs approved by the U.S. FDA between 2000 and 2015. Specifically, we focused on seven classes of new molecular entity (NME) classified by the anatomic therapeutic chemical (ATC) classification system. They were NMEs and their corresponding targets for the cardiovascular system, respiratory system, nerve system, general anti-infective systemic, genito-urinary system and sex hormones, alimentary tract and metabolisms, and antineoplastic and immunomodulating agents...
September 25, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28931315/the-liver-toxicity-knowledge-base-lktb-and-drug-induced-liver-injury-dili-classification-for-assessment-of-human-liver-injury
#6
Shraddha Thakkar, Weida Tong, Minjun Chen, Hong Fang, Zhichao Liu, Ruth Roberts
Drug-induced liver injury (DILI) is challenging drug development, clinical practice and regulation. The Liver Toxicity Knowledge Base (LTKB) provides essential data for DILI study. Areas Covered: The LTKB provided various types of data that can be used to assess and predict DILI. Among much information available, several reference drug lists with annotated human DILI risk are of important. The LTKB DILI classification data include DILI severity concern determined by the FDA drug labeling, DILI severity score from the NIH LiverTox database, and other DILI classification schemes from the literature...
September 21, 2017: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28895231/software-related-recalls-of-health-information-technology-and-other-medical-devices-implications-for-fda-regulation-of-digital-health
#7
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/28753262/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-closed-loop-hysteroscopic-insufflator-with-cutter-coagulator-final-order
#8
(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
#9
(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
#10
(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
#11
(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
#12
(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
#13
(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
#14
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
#15
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...
November 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
#16
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
#17
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
#18
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
#19
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
#20
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
keyword
keyword
114374
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"