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FDA Drug Classification

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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
#1
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
#2
(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
#3
(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
#4
(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
#5
(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
#6
(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 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29319941/medical-devices-radiology-devices-classification-of-the-rectal-balloon-for-prostate-immobilization-final-order
#7
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization 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 rectal balloon for prostate immobilization'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 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29319940/medical-devices-neurological-devices-classification-of-the-external-vagal-nerve-stimulator-for-headache-final-order
#8
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache 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 external vagal nerve stimulator for headache'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 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29319939/medical-devices-neurological-devices-classification-of-the-computerized-behavioral-therapy-device-for-psychiatric-disorders-final-order
#9
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders 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 computerized behavioral therapy device for psychiatric disorders' 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 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29319938/medical-devices-hematology-and-pathology-devices-classification-of-the-flow-cytometric-test-system-for-hematopoietic-neoplasms-final-order
#10
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms 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 flow cytometric test system for hematopoietic neoplasms' 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 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29319937/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-reagents-for-molecular-diagnostic-instrument-test-systems-final-order
#11
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general 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.
December 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29274631/medical-devices-anesthesiology-devices-classification-of-the-external-negative-pressure-airway-aid-final-order
#12
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid 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 external negative pressure airway aid'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 26, 2017: Federal Register
https://www.readbyqxmd.com/read/29260838/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-image-processing-device-for-estimation-of-external-blood-loss-final-order
#13
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss 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 image processing device for estimation of external blood loss' 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 20, 2017: Federal Register
https://www.readbyqxmd.com/read/29242895/comparison-of-laboratory-developed-tests-and-fda-approved-assays-for-braf-egfr-and-kras-testing
#14
Annette S Kim, Angela N Bartley, Julia A Bridge, Suzanne Kamel-Reid, Alexander J Lazar, Neal I Lindeman, Thomas A Long, Jason D Merker, Alex J Rai, David L Rimm, Paul G Rothberg, Patricia Vasalos, Joel T Moncur
Importance: The debate about the role of the Food and Drug Administration (FDA) in the regulation of laboratory-developed tests (LDTs) has focused attention on the analytical performance of all clinical laboratory testing. This study provides data comparing the performance of LDTs and FDA-approved companion diagnostics (FDA-CDs) in proficiency testing (PT) provided by the College of American Pathologists Molecular Oncology Committee. Objective: To compare the analytical performance of LDTs and FDA-CDs on well-characterized PT samples and to compare the practice characteristics of laboratories using these assays...
December 14, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/29231691/medical-devices-gastroenterology-urology-devices-classification-of-the-prostatic-artery-embolization-device-final-order
#15
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the prostatic artery embolization 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 prostatic artery embolization 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...
November 14, 2017: Federal Register
https://www.readbyqxmd.com/read/29231688/medical-devices-immunology-and-microbiology-devices-classification-of-the-automated-indirect-immunofluorescence-microscope-and-software-assisted-system-final-order
#16
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the automated indirect immunofluorescence microscope and software-assisted 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 automated indirect immunofluorescence microscope and software-assisted 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 14, 2017: Federal Register
https://www.readbyqxmd.com/read/29209918/molecular-classification-and-precision-therapy-of-cancer-immune-checkpoint-inhibitors
#17
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
#18
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
#19
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
#20
(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
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