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FDA Drug Classification

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https://www.readbyqxmd.com/read/27901563/medical-devices-ear-nose-and-throat-devices-classification-of-the-eustachian-tube-balloon-dilation-system-final-order
#1
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system 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 Eustachian tube balloon dilation system'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.
October 24, 2016: Federal Register
https://www.readbyqxmd.com/read/27901560/medical-devices-physical-medicine-devices-classification-of-the-upper-extremity-prosthesis-including-a-simultaneously-powered-elbow-and-or-shoulder-with-greater-than-two-simultaneous-powered-degrees-of-freedom-and-controlled-by-non-implanted-electrical-components
#2
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components 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 upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' classification...
October 18, 2016: Federal Register
https://www.readbyqxmd.com/read/27901558/medical-devices-cardiovascular-devices-classification-of-the-apical-closure-device-final-order
#3
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the apical closure 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 apical closure 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.
October 17, 2016: Federal Register
https://www.readbyqxmd.com/read/27895719/drabal-novel-method-to-mine-large-high-throughput-screening-assays-using-bayesian-active-learning
#4
Othman Soufan, Wail Ba-Alawi, Moataz Afeef, Magbubah Essack, Panos Kalnis, Vladimir B Bajic
BACKGROUND: Mining high-throughput screening (HTS) assays is key for enhancing decisions in the area of drug repositioning and drug discovery. However, many challenges are encountered in the process of developing suitable and accurate methods for extracting useful information from these assays. Virtual screening and a wide variety of databases, methods and solutions proposed to-date, did not completely overcome these challenges. This study is based on a multi-label classification (MLC) technique for modeling correlations between several HTS assays, meaning that a single prediction represents a subset of assigned correlated labels instead of one label...
2016: Journal of Cheminformatics
https://www.readbyqxmd.com/read/27836481/a-systematic-review-of-rapid-diagnostic-tests-for-influenza-considerations-for-the-community-pharmacist
#5
REVIEW
Renee R Koski, Michael E Klepser
OBJECTIVES: Rapid influenza diagnostic tests (RIDTs) have a potential role in community pharmacy to optimize influenza infection management. The U.S. Food and Drug Administration (FDA) proposed changes to the classification of RIDTs may affect their use in community pharmacy. We reviewed the performance and features of RIDTs likely to meet FDA-proposed reclassification requirements. DATA SOURCES: PubMed and Medline database searches were performed using the terms "Sofia Influenza A and B Fluorescent Immunoassay," "BD Veritor System for Rapid Detection of Flu A and B", and "Alere i Influenza A and B...
November 8, 2016: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/27766937/leveraging-graph-topology-and-semantic-context-for-pharmacovigilance-through-twitter-streams
#6
Ryan Eshleman, Rahul Singh
BACKGROUND: Adverse drug events (ADEs) constitute one of the leading causes of post-therapeutic death and their identification constitutes an important challenge of modern precision medicine. Unfortunately, the onset and effects of ADEs are often underreported complicating timely intervention. At over 500 million posts per day, Twitter is a commonly used social media platform. The ubiquity of day-to-day personal information exchange on Twitter makes it a promising target for data mining for ADE identification and intervention...
October 6, 2016: BMC Bioinformatics
https://www.readbyqxmd.com/read/27726321/medical-devices-neurological-devices-classification-of-the-evoked-photon-image-capture-device-final-order
#7
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
September 30, 2016: Federal Register
https://www.readbyqxmd.com/read/27706385/innovative-in-vitro-methodologies-for-establishing-therapeutic-equivalence
#8
Lisa Murray, Antonio Arias, Jibin Li, Sid Bhoopathy, Ismael J Hidalgo
To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely on clinical studies to comply with this requirement. Instead, it makes sense to adopt or develop strategies that are appropriate to the characteristics of the region. To streamline drug development and accelerate patients' access to quality drug products, 15 years ago the United States Food and Drug Administration (FDA) decided to grant exemptions from clinical bioequivalence studies (i...
August 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/27658316/medical-devices-ophthalmic-devices-classification-of-strabismus-detection-device-final-order
#9
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the strabismus detection 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 strabismus detection 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.
September 22, 2016: Federal Register
https://www.readbyqxmd.com/read/27658314/medical-devices-general-and-plastic-surgery-devices-classification-of-the-magnetic-surgical-instrument-system-final-order
#10
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System 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 magnetic surgical instrument system'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.
September 21, 2016: Federal Register
https://www.readbyqxmd.com/read/27549225/transvaginal-mesh-a-historical-review-and-update-of-the-current-state-of-affairs-in-the-united-states
#11
Shilpa Iyer, Sylvia M Botros
INTRODUCTION: Transvaginal mesh usage has been at the forefront of popular media and academic debate for the past 10 years. Several US Food and Drug Administration (FDA) communications, society statements, and research articles have been written in an attempt to define and articulate the classification system, safety data, and efficacy of this approach to transvaginal surgery. In this review, we explore the history of transvaginal mesh surgery for pelvic organ prolapse (POP), review FDA and society statements, and research current practice in the United States...
August 22, 2016: International Urogynecology Journal
https://www.readbyqxmd.com/read/27477818/probability-based-herg-blocker-classifiers
#12
Zhi Wang, Hamse Y Mussa, Robert Lowe, Robert C Glen, Aixia Yan
The US Food and Drug Administration (FDA) require in vitro human ether-a-go-go related (hERG) ion channel affinity tests for all drug candidates prior to clinical trials. In this study, probabilistic-based methods were employed to develop prediction models on hERG inhibition prediction, which are different from traditional QSAR models that are mainly based on supervised 'hard point' (HP) classification approaches giving 'yes/no' answers. The obtained models can 'ascertain' whether or not a given set of compounds can block hERG ion channels...
September 2012: Molecular Informatics
https://www.readbyqxmd.com/read/27466762/computational-regulatory-developments-in-the-prediction-of-oral-drug-absorption
#13
REVIEW
G Valsami, P Macheras
Early prediction of human intestinal absorption is important in selection of potential orally administered drugs. Various computational models for prediction of the fraction of dose absorbed, Fa, have been developed. In 1989, a sigmoidal relationship between Fa and drug absorption potential was shown. Since then various physicochemical descriptors of molecules (lipophilicity, polar surface area, hydrogen bond descriptors) have been found to correlate with human intestinal absorption and various attempts in estimating Fa have been reported...
March 14, 2011: Molecular Informatics
https://www.readbyqxmd.com/read/27459751/physical-medicine-devices-reclassification-of-iontophoresis-device-intended-for-any-other-purposes-final-order
#14
(no author information available yet)
The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.
July 26, 2016: Federal Register
https://www.readbyqxmd.com/read/27446855/clinical-trial-risk-in-hepatitis-c-endpoint-selection-and-drug-action
#15
Nicole A Tillie, Jayson L Parker, Jordan J Feld
Background and Aims. This study analyzed the risk of clinical trial failure of new drugs for hepatitis C between January 1998 and January 2015. Methods. Hepatitis C drug development trials that were in phases I-III of clinical trial testing were obtained from the publicly accessible clinical trial repository and other publicly available databases. Drug compounds were excluded from the study if they began their phase I testing before 1998, if they were not industry sponsored, or if they treated secondary complications of hepatitis C...
2016: Canadian Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27411238/medical-devices-gastroenterology-urology-devices-classification-of-the-metallic-biliary-stent-system-for-benign-strictures-final-order
#16
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures 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 metallic biliary stent system for benign strictures' 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 13, 2016: Federal Register
https://www.readbyqxmd.com/read/27400464/medical-devices-neurological-devices-classification-of-the-thermal-system-for-insomnia-final-order
#17
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the thermal system for insomnia 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 thermal system for insomnia'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 11, 2016: Federal Register
https://www.readbyqxmd.com/read/27396596/gradually-expanding-scope-for-biowaivers-an-overview
#18
Vikrant Saluja, Amanpreet Singh, Adnan Mohammed Algradi
The regulatory paradigm is relaxing gradually without compromising the safety, efficacy and the quality of the product and, most importantly, a perceptible scientific consensus is maturing towards the need of affordable medicines. The establishment of bioequivalence (BE) is no longer being considered to be accomplished only by in vivo studies in oral drug products. The potential use of in vitro dissolution testing in lieu of BE studies has now been regulatory adopted and is commonly referred to as "biowaiver"...
July 7, 2016: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/27373015/medical-devices-general-and-plastic-surgery-devices-classification-of-the-electrosurgical-device-for-over-the-counter-aesthetic-use-final-order
#19
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic 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 electrosurgical device for over-the-counter aesthetic use'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.
June 29, 2016: Federal Register
https://www.readbyqxmd.com/read/27328463/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-gynecologic-laparoscopic-power-morcellation-containment-system-final-order
#20
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system 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 gynecologic laparoscopic power morcellation containment system'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...
June 21, 2016: Federal Register
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