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FDA Drug Classification

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https://www.readbyqxmd.com/read/29882797/targeting-histone-deacetylases-with-natural-and-synthetic-agents-an-emerging-anticancer-strategy
#1
REVIEW
Amit Kumar Singh, Anupam Bishayee, Abhay K Pandey
Cancer initiation and progression are the result of genetic and/or epigenetic alterations. Acetylation-mediated histone/non-histone protein modification plays an important role in the epigenetic regulation of gene expression. Histone modification is controlled by the balance between histone acetyltransferase and (HAT) and histone deacetylase (HDAC) enzymes. Imbalance between the activities of these two enzymes is associated with various forms of cancer. Histone deacetylase inhibitors (HDACi) regulate the activity of HDACs and are being used in cancer treatment either alone or in combination with other chemotherapeutic drugs/radiotherapy...
June 6, 2018: Nutrients
https://www.readbyqxmd.com/read/29880031/ontology-based-literature-mining-and-class-effect-analysis-of-adverse-drug-reactions-associated-with-neuropathy-inducing-drugs
#2
Junguk Hur, Arzucan Özgür, Yongqun He
BACKGROUND: Adverse drug reactions (ADRs), also called as drug adverse events (AEs), are reported in the FDA drug labels; however, it is a big challenge to properly retrieve and analyze the ADRs and their potential relationships from textual data. Previously, we identified and ontologically modeled over 240 drugs that can induce peripheral neuropathy through mining public drug-related databases and drug labels. However, the ADR mechanisms of these drugs are still unclear. In this study, we aimed to develop an ontology-based literature mining system to identify ADRs from drug labels and to elucidate potential mechanisms of the neuropathy-inducing drugs (NIDs)...
June 7, 2018: Journal of Biomedical Semantics
https://www.readbyqxmd.com/read/29868550/reverse-screening-methods-to-search-for-the-protein-targets-of-chemopreventive-compounds
#3
REVIEW
Hongbin Huang, Guigui Zhang, Yuquan Zhou, Chenru Lin, Suling Chen, Yutong Lin, Shangkang Mai, Zunnan Huang
This article is a systematic review of reverse screening methods used to search for the protein targets of chemopreventive compounds or drugs. Typical chemopreventive compounds include components of traditional Chinese medicine, natural compounds and Food and Drug Administration (FDA)-approved drugs. Such compounds are somewhat selective but are predisposed to bind multiple protein targets distributed throughout diverse signaling pathways in human cells. In contrast to conventional virtual screening, which identifies the ligands of a targeted protein from a compound database, reverse screening is used to identify the potential targets or unintended targets of a given compound from a large number of receptors by examining their known ligands or crystal structures...
2018: Frontiers in Chemistry
https://www.readbyqxmd.com/read/29857426/exploring-health-information-technology-events-from-fda-maude-database
#4
Bin Yao, Hong Kang, Ju Wang, Sicheng Zhou, Yang Gong
To facilitate preventing patient safety events, researchers have been using the Federal Drug Administration (FDA) Manufacturer and User Device Experience (MAUDE) database as a publicly accessible data source for retrieving reports of medical devices including Health Information Technology (HIT) devices. A combined search strategy built with keywords in several fields such as Generic Name, Brand Name and Manufacturer is commonly used to extract reports of specific classifications of devices in the MAUDE. However, another structured field, Classification Product Code, is rarely visited...
2018: Studies in Health Technology and Informatics
https://www.readbyqxmd.com/read/29794033/prediction-of-response-to-drug-therapy-in-psychiatric-disorders
#5
REVIEW
Shani Stern, Sara Linker, Krishna C Vadodaria, Maria C Marchetto, Fred H Gage
Personalized medicine has become increasingly relevant to many medical fields, promising more efficient drug therapies and earlier intervention. The development of personalized medicine is coupled with the identification of biomarkers and classification algorithms that help predict the responses of different patients to different drugs. In the last 10 years, the Food and Drug Administration (FDA) has approved several genetically pre-screened drugs labelled as pharmacogenomics in the fields of oncology, pulmonary medicine, gastroenterology, haematology, neurology, rheumatology and even psychiatry...
May 2018: Open Biology
https://www.readbyqxmd.com/read/29754585/significance-and-implications-of-fda-approval-of-pembrolizumab-for-biomarker-defined-disease
#6
Michael M Boyiadzis, John M Kirkwood, John L Marshall, Colin C Pritchard, Nilofer S Azad, James L Gulley
The U.S. Food and Drug Administration (FDA) recently approved pembrolizumab, an anti- programmed cell death protein 1 cancer immunotherapeutic, for use in advanced solid tumors in patients with the microsatellite-high/DNA mismatch repair-deficient biomarker. This is the first example of a tissue-agnostic FDA approval of a treatment based on a patient's tumor biomarker status, rather than on tumor histology. Here we discuss key issues and implications arising from the biomarker-based disease classification implied by this historic approval...
May 14, 2018: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29686151/analysis-of-clinical-drug-drug-interaction-data-to-predict-uncharacterized-interaction-magnitudes-between-antiretroviral-drugs-and-co-medications
#7
Felix Stader, Hannah Kinvig, Manuel Battegay, Saye Khoo, Andrew Owen, Marco Siccardi, Catia Marzolini
Despite their high potential for drug-drug-interactions (DDI), clinical DDI studies of antiretroviral drugs (ARVs) are often lacking, because the full range of potential interactions cannot feasibly or pragmatically be studied, with some high-risk DDI studies also ethically difficult to undertake. Thus, a robust method to screen and to predict the likelihood of DDIs is required.We developed a method to predict DDIs based on two parameters: the degree of metabolism by specific enzymes such as CYP3A and the strength of an inhibitor or inducer...
April 23, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29653261/assessment-of-obstetric-and-gynecologic-food-and-drug-administration-device-approvals-and-recalls
#8
Sheena Galhotra, Joseph Maurice
STUDY OBJECTIVE: To evaluate and compare the recall rates of obstetric and gynecologic devices approved via the Food and Drug Administration's 510(k) and premarket approval (PMA) processes. DESIGN: A retrospective observational study (Canadian Task Force classification II-2). SETTING: Clinical settings in the United States that use obstetric and gynecologic devices. SUBJECTS: Two thousand two hundred forty-nine Food and Drug Administration-approved obstetric and gynecologic devices that were recalled between November 1, 2002, and December 31, 2017...
April 10, 2018: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/29571740/biowaiver-monographs-for-immediate-release-solid-oral-dosage-forms-proguanil-hydrochloride
#9
Gerlinde F Plöger, Bertil Abrahamsson, Rodrigo Cristofoletti, Dirk W Groot, Peter Langguth, Mehul U Mehta, Alan Parr, James E Polli, Vinod P Shah, Tomokazu Tajiri, Jennifer B Dressman
Literature data relevant to the decision to waive in vivo bioequivalence testing for the approval of generic immediate release solid oral dosage forms of proguanil hydrochloride are reviewed. To elucidate the Biopharmaceutics Classification System (BCS) classification, experimental solubility and dissolution studies were also carried out. The antimalarial proguanil hydrochloride, effective via the parent compound proguanil and the metabolite cycloguanil, is not considered to be a narrow therapeutic index drug...
March 20, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29540830/classifying-braf-alterations-in-cancer-new-rational-therapeutic-strategies-for-actionable-mutations
#10
REVIEW
Matthew Dankner, April A N Rose, Shivshankari Rajkumar, Peter M Siegel, Ian R Watson
The RAS-RAF-MEK-ERK signaling cascade is among the most frequently mutated pathways in human cancer. Approximately 50% of melanoma patients possess a druggable hotspot V600E/K mutation in the BRAF protein kinase. FDA-approved combination therapies of BRAF and MEK inhibitors are available that provide survival benefits to patients with a BRAF V600 mutation. Non-V600 BRAF mutants are found in many cancers, and are more prevalent than V600 mutations in certain tumor types. For example, between 50-80% of BRAF mutations in non-small cell lung cancer and 22-30% in colorectal cancer encode for non-V600 mutants...
March 15, 2018: Oncogene
https://www.readbyqxmd.com/read/29504419/-vaginal-mesh-operations-in-the-urogynecological-practice-after-the-fda-warnings-use-or-not-to-use-mesh
#11
Zoltán Fekete, Szilvia Körösi, Gábor Németh
INTRODUCTION: The prevalence of pelvic organ prolapse (POP) with aging is escalating alarmingly, and now becoming a growing epidemic among the elderly. Synthetic transvaginal mesh (TVM) has been employed with increasing popularity in the treatment of POP until the end of the last decade. After the U.S. Drug and Food Administration (FDA) warnings in the years 2008 and 2011, the number of vaginal mesh operations has decreased dramatically. AIM: The aim of the study was to evaluate and compare the anti-POP effectivity, the anti-stress incontinence (anti-SUI) efficacy, and the late (36 months) post-operative complications of the anterior vaginoplasty and the TVM operations...
March 2018: Orvosi Hetilap
https://www.readbyqxmd.com/read/29482205/association-of-coprescription-of-triptan-antimigraine-drugs-and-selective-serotonin-reuptake-inhibitor-or-selective-norepinephrine-reuptake-inhibitor-antidepressants-with-serotonin-syndrome
#12
Yulia Orlova, Paul Rizzoli, Elizabeth Loder
Importance: In 2006, the US Food and Drug Administration (FDA) issued an advisory warning on the risk of serotonin syndrome with concomitant use of triptans and selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI) antidepressants, but the true risk of serotonin syndrome in these patients remains unknown. Objective: To assess the risk of serotonin syndrome with concomitant use of triptans and SSRI or SNRI antidepressants...
February 26, 2018: JAMA Neurology
https://www.readbyqxmd.com/read/29460613/medical-devices-general-and-plastic-surgery-devices-classification-of-the-surgical-smoke-precipitator-final-order
#13
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator 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 surgical smoke precipitator'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...
January 30, 2018: Federal Register
https://www.readbyqxmd.com/read/29460606/medical-devices-cardiovascular-devices-classification-of-the-temporary-catheter-for-embolic-protection-during-transcatheter-intracardiac-procedures-final-order
#14
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures 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 temporary catheter for embolic protection during transcatheter intracardiac procedures' 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...
January 30, 2018: Federal Register
https://www.readbyqxmd.com/read/29383146/tumor-exome-sequencing-and-copy-number-alterations-reveal-potential-predictors-of-intrinsic-resistance-to-multi-targeted-tyrosine-kinase-inhibitors
#15
Nancy K Gillis, Daniel M Rotroff, Tania E Mesa, Jiqiang Yao, Zhihua Chen, Michael A Carulli, Sean J Yoder, Christine M Walko, Jamie K Teer, Howard L McLeod
Multi-targeted tyrosine kinase inhibitors (TKIs) have broad efficacy and similar FDA-approved indications, suggesting shared molecular drug targets across cancer types. Irrespective of tumor type, 20-30% of patients treated with multi-targeted TKIs demonstrate intrinsic resistance, with progressive disease as a best response. We conducted a retrospective cohort study to identify tumor (somatic) point mutations, insertion/deletions, and copy number alterations (CNA) associated with intrinsic resistance to multi-targeted TKIs...
December 29, 2017: Oncotarget
https://www.readbyqxmd.com/read/29320138/medical-devices-radiology-devices-classification-of-the-absorbable-perirectal-spacer-final-order
#16
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer 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 absorbable perirectal spacer'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...
January 5, 2018: Federal Register
https://www.readbyqxmd.com/read/29319946/medical-devices-hematology-and-pathology-devices-classification-of-a-cervical-intraepithelial-neoplasia-test-system-final-order
#17
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system 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 CIN test system'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...
January 3, 2018: Federal Register
https://www.readbyqxmd.com/read/29319945/medical-devices-general-and-plastic-surgery-devices-classification-of-the-irrigating-wound-retractor-device-final-order
#18
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device 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 irrigating wound retractor device'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...
January 2, 2018: Federal Register
https://www.readbyqxmd.com/read/29319944/medical-devices-hematology-and-pathology-devices-classification-of-the-whole-slide-imaging-system-final-order
#19
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system 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 whole slide imaging system'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...
January 2, 2018: Federal Register
https://www.readbyqxmd.com/read/29319942/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-pressure-wedge-for-the-reduction-of-cesarean-delivery-final-order
#20
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery 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 pressure wedge for the reduction of cesarean delivery'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...
December 28, 2017: Federal Register
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