Results 71 to 80 of about 831,296 (284)

Characteristics and use of patient-reported outcomes of clinical trials for high-risk neurological medical devices that received FDA premarket approval from 2001 to 2022

open access: yesContemporary Clinical Trials Communications
Neurological medical devices have revolutionized the management of neurological disorders, providing diagnostic, therapeutic, and monitoring solutions.
Morgan E. Ryan   +4 more
doaj   +1 more source

Exploiting metabolic adaptations to overcome dabrafenib treatment resistance in melanoma cells

open access: yesMolecular Oncology, EarlyView.
We show that dabrafenib‐resistant melanoma cells undergo mitochondrial remodeling, leading to elevated respiration and ROS production balanced by stronger antioxidant defenses. This altered redox state promotes survival despite mitochondrial damage but renders resistant cells highly vulnerable to ROS‐inducing compounds such as PEITC, highlighting redox
Silvia Eller   +17 more
wiley   +1 more source

Communicating Healthcare Economic and Pre-approval Information With Healthcare Decision-Makers: Opportunities Following the 21st Century Cures Act and FDA Guidance

open access: yesFrontiers in Public Health, 2018
With rising US healthcare costs, population health decision-makers have expressed interest in receiving pre-approval information to help with the budgeting and forecasting needed to accommodate pharmaceutical and medical device launches.
Alexander Niyazov, Denise Lenci
doaj   +1 more source

Voting behavior during FDA Medical Device Advisory Committee panel meetings.

open access: yesPLoS ONE, 2022
ObjectivesDuring premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for approval.
Amanda Maisel-Campbell   +9 more
doaj   +1 more source

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes [PDF]

open access: yes, 2005
Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this
Lavender, Mark
core   +1 more source

ATF4‐mediated stress response as a therapeutic vulnerability in chordoma

open access: yesMolecular Oncology, EarlyView.
We screened 5 chordoma cell lines against 100+ inhibitors of epigenetic and metabolic pathways and kinases and identified halofuginone, a tRNA synthetase inhibitor. Mechanistically halofuginone induces an integrated stress response, with eIF2alpha phosphorylation, activation of ATF4 and its target genes CHOP, ASNS, INHBE leading to cell death ...
Lucia Cottone   +11 more
wiley   +1 more source

Developing evidence‐based, cost‐effective P4 cancer medicine for driving innovation in prevention, therapeutics, patient care and reducing healthcare inequalities

open access: yesMolecular Oncology, EarlyView.
The cancer problem is increasing globally with projections up to the year 2050 showing unfavourable outcomes in terms of incidence and cancer‐related deaths. The main challenges are prevention, improved therapeutics resulting in increased cure rates and enhanced health‐related quality of life.
Ulrik Ringborg   +43 more
wiley   +1 more source

Infrared laser sampling of low volumes combined with shotgun lipidomics reveals lipid markers in palatine tonsil carcinoma

open access: yesMolecular Oncology, EarlyView.
Nanosecond infrared laser (NIRL) low‐volume sampling combined with shotgun lipidomics uncovers distinct lipidome alterations in oropharyngeal squamous cell carcinoma (OPSCC) of the palatine tonsil. Several lipid species consistently differentiate tumor from healthy tissue, highlighting their potential as diagnostic markers.
Leonard Kerkhoff   +11 more
wiley   +1 more source

Mobile transactions over NFC and GSM [PDF]

open access: yes, 2014
Dynamic relationships between Near Field Communication (NFC) ecosystem players in a monetary transaction make them partners in a way that they sometimes require to share access permission to applications that are running in the service environment.
Ghinea, G   +3 more
core  

Peroxidasin enables melanoma immune escape by inhibiting natural killer cell cytotoxicity

open access: yesMolecular Oncology, EarlyView.
Peroxidasin (PXDN) is secreted by melanoma cells and binds the NK cell receptor NKG2D, thereby suppressing NK cell activation and cytotoxicity. PXDN depletion restores NKG2D signaling and enables effective NK cell–mediated melanoma killing. These findings identify PXDN as a previously unrecognized immune evasion factor and a potential target to improve
Hsu‐Min Sung   +17 more
wiley   +1 more source

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