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https://www.readbyqxmd.com/read/29209918/molecular-classification-and-precision-therapy-of-cancer-immune-checkpoint-inhibitors
#1
Yingyan Yu
On May 23, 2017, the US Food and Drug Administration (FDA) approved a treatment for cancer patients with positive microsatellite instability-high (MSI-H) markers or mismatch repair deficient (dMMR) markers. This approach is the first approved tumor treatment using a common biomarker rather than specified tumor locations in the body. FDA previously approved Keytruda for treatment of several types of malignancies, such as metastatic melanoma, metastatic non-small-cell lung cancer, recurrent or metastatic head and neck cancer, refractory Hodgkin lymphoma, and urothelial carcinoma, all of which carry positive programmed death-1/programmed death-ligand 1 biomarkers...
December 5, 2017: Frontiers of Medicine
https://www.readbyqxmd.com/read/29200110/high-grade-gliomas
#2
Lakshmi Nayak, David A Reardon
PURPOSE OF REVIEW: This article reviews the standard treatment for high-grade gliomas, with a focus on promising new strategies and response assessment. RECENT FINDINGS: The new World Health Organization (WHO) classification of central nervous system tumors classifies high-grade gliomas based on molecular markers that are of prognostic and therapeutic significance. The addition of chemotherapy, specifically procarbazine, CCNU (lomustine), and vincristine, to radiation in newly diagnosed 1p/19q codeleted anaplastic oligodendrogliomas doubled overall survival...
December 2017: Continuum: Lifelong Learning in Neurology
https://www.readbyqxmd.com/read/29128423/amorphous-solid-dispersions-and-nanocrystal-technologies-for-poorly-water-soluble-drug-delivery-an-update
#3
Scott V Jermain, Chris Brough, Robert O Williams
Poor water-solubility remains a typical property of drug candidates in pharmaceutical development pipelines today. Various processes have been developed to increase the solubility, dissolution rate, and bioavailability of these active ingredients belonging to biopharmaceutical classification system (BCS) II and IV classifications. Since the early 2000s, nanocrystal delivery and amorphous solid dispersions are more established techniques to overcome the limitations of poorly-water soluble drugs in FDA available products...
November 8, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29111623/medical-devices-exemption-from-premarket-notification-class-ii-devices-autosomal-recessive-carrier-screening-gene-mutation-detection-system-final-order
#4
(no author information available yet)
The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations...
November 7, 2017: Federal Register
https://www.readbyqxmd.com/read/29111622/medical-devices-immunology-and-microbiology-devices-classification-of-the-genetic-health-risk-assessment-system-final-order
#5
(no author information available yet)
The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment 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 genetic health risk assessment 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...
November 7, 2017: Federal Register
https://www.readbyqxmd.com/read/29111621/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-total-25-hydroxyvitamin-d-mass-spectrometry-test-system-final-order
#6
(no author information available yet)
The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry 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 total 25-hydroxyvitamin D mass spectrometry 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...
November 7, 2017: Federal Register
https://www.readbyqxmd.com/read/29091372/medical-devices-immunology-and-microbiology-devices-classification-of-the-bcr%C3%A2-abl-quantitation-test-final-order
#7
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the BCR-ABL quantitation test 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 BCR-ABL quantitation test'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...
November 1, 2017: Federal Register
https://www.readbyqxmd.com/read/29091371/medical-devices-immunology-and-microbiology-devices-classification-of-the-newborn-screening-test-for-severe-combined-immunodeficiency-disorder-final-order
#8
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) 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 newborn screening test for SCID'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 30, 2017: Federal Register
https://www.readbyqxmd.com/read/29091370/medical-devices-immunology-and-microbiology-devices-classification-of-the-aquaporin-4-autoantibody-immunological-test-system-final-order
#9
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the Aquaporin-4 autoantibody immunological 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 Aquaporin-4 autoantibody immunological 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...
October 30, 2017: Federal Register
https://www.readbyqxmd.com/read/29091369/medical-devices-immunology-and-microbiology-devices-classification-of-the-streptococcus-spp-nucleic-acid-based-assay-final-order
#10
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the Streptococcus spp. nucleic acid-based assay 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 Streptococcus spp. nucleic acid-based assay'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 30, 2017: Federal Register
https://www.readbyqxmd.com/read/29091368/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-acute-kidney-injury-test-system-final-order
#11
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the acute kidney injury 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 acute kidney injury 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...
October 30, 2017: Federal Register
https://www.readbyqxmd.com/read/29090893/medical-devices-immunology-and-microbiology-devices-classification-of-the-zinc-transporter-8-autoantibody-immunological-test-system-final-order
#12
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the zinc transporter 8 autoantibody immunological 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 zinc transporter 8 autoantibody immunological 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...
October 24, 2017: Federal Register
https://www.readbyqxmd.com/read/29090892/medical-devices-immunology-and-microbiology-devices-classification-of-the-mass-spectrometer-system-for-clinical-use-for-the-identification-of-microorganisms-final-order
#13
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the mass spectrometer system for clinical use for the identification of microorganisms 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 mass pectrometer system for clinical use for the identification of microorganisms' 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 24, 2017: Federal Register
https://www.readbyqxmd.com/read/29090891/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and-measure-non-microbial-analyte-s-in-human-clinical-specimens-to-aid-in-assessment-of-patients-with-suspected-sepsis-final-order
#14
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis 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 device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification...
October 24, 2017: Federal Register
https://www.readbyqxmd.com/read/29090889/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and-identify-microbial-pathogen-nucleic-acids-in-cerebrospinal-fluid-final-order
#15
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’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 20, 2017: Federal Register
https://www.readbyqxmd.com/read/29076742/impact-of-the-us-fda-biopharmaceutics-classification-system-bcs-guidance-on-global-drug-development
#16
Mehul U Mehta, Ramana S Uppoor, Dale P Conner, Paul Seo, Jayabharathi Vaidyanathan, Donna A Volpe, Ethan Stier, Dakshina Chilukuri, Angelica Dorantes, Tapash Ghosh, Haritha Mandula, Kimberly Raines, Pariban Dhanormchitphong, Janet Woodcock, Lawrence X Yu
The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry toward its implementation and further expansion. This article describes how the review implementation of this guidance was undertaken at the FDA and results of these efforts over last dozen years or so across the new, and the generic, drug domains are provided...
November 7, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/29061979/hipsc-cm-monolayer-maturation-state-determines-drug-responsiveness-in-high-throughput-pro-arrhythmia-screen
#17
André Monteiro da Rocha, Katherine Campbell, Sergey Mironov, Jiang Jiang, Lakshmi Mundada, Guadalupe Guerrero-Serna, José Jalife, Todd J Herron
Human induced pluripotent stem cell derived cardiomyocytes (hiPSC-CMs) offer a novel in vitro platform for pre-clinical cardiotoxicity and pro-arrhythmia screening of drugs in development. To date hiPSC-CMs used for cardiotoxicity testing display an immature, fetal-like cardiomyocyte structural and electrophysiological phenotype which has called into question the applicability of hiPSC-CM findings to the adult heart. The aim of the current work was to determine the effect of cardiomyocyte maturation state on hiPSC-CM drug responsiveness...
October 23, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29048701/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-organophosphate-test-system-final-order
#18
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the organophosphate 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 organophosphate 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...
October 18, 2017: Federal Register
https://www.readbyqxmd.com/read/29035495/medical-devices-gastroenterology-urology-devices-classification-of-the-enzyme-packed-cartridge-final-order
#19
(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
#20
(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
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