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https://www.readbyqxmd.com/read/29653261/assessment-of-obstetric-and-gynecologic-fda-device-approvals-and-recalls
#1
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 (FDA) 510(k) and Premarket Approval (PMA) processes DESIGN: Retrospective Observational Study (Canadian Task Force Classification II-2) SETTING: Clinical settings in the United States of America that use Obstetric and Gynecologic devices SUBJECTS: 2,249 FDA 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
#2
Gerlinde F Plöger, Bertil Abrahamsson, Rodrigo Cristofoletti, D I R K 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 clarify 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
#3
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
#4
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
#5
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
#6
(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
#7
(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
#8
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
#9
(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
#10
(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
#11
(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
#12
(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
#13
(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
https://www.readbyqxmd.com/read/29319941/medical-devices-radiology-devices-classification-of-the-rectal-balloon-for-prostate-immobilization-final-order
#14
(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
#15
(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
#16
(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
#17
(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
#18
(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
#19
(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
#20
(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
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