This study examines the Food and Drug Administration’s accelerated approval pathway and whether preapproval initiation was associated with faster conversion to traditional approval or withdrawal for drugs with nononcology indications.
Risultati per: La FDA approva il sistema di riabilitazione dell’ictus
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FDA Approves First Oral Treatment for Kidney Disease–Induced Anemia
The US Food and Drug Administration (FDA) has approved the first oral treatment for anemia caused by chronic kidney disease.
Genenta ottiene la designazione di farmaco orfano dalla Fda
La terapia cellulare per il trattamento del glioblastoma multiforme, tumore cerebrale molto aggressivo, rappresenta un cambio di paradigma nell’approccio a una malattia che a oggi non ha una cura
Trends in FDA Adverse Events Reporting for Inferior Vena Cava Filters in the US
This quality improvement study identifies adverse events for inferior vena cava filters and reports changes in adverse event reporting and estimated insertions between 2016 and 2020 in the US.
FDA Proposes Individual Risk Assessment for Blood Donation
The US Food and Drug Administration (FDA) has announced proposed changes in its recommendations governing blood donor eligibility to reduce the risk of transfusion-transmitted HIV. The proposed guidance assesses risk using gender-inclusive, individual questionnaires rather than using broad time-based deferrals.
Usa, Fda autorizza primo test casalingo per Covid-influenza
E’ un tampone nasale, risultati in 30 minuti
Alliance for Hippocratic Medicine v. FDA — Dobbs’s Collateral Consequences for Pharmaceutical Regulation
New England Journal of Medicine, Ahead of Print.
Emicrania, Fda designa come rivoluzionario farmaco digitale
In sviluppo per tipo episodico,piattaforma e app contro attacchi
Riabilitazione cognitiva a seguito di trauma cranico
Lecanemab Gains FDA Approval for Early Alzheimer Disease
A treatment that may moderately slow mild cognitive decline and reduce amyloid-β plaques in patients with early Alzheimer disease gained accelerated approval from the US Food and Drug Administration (FDA). Lecanemab-irmb, marketed as Leqembi by Eisai and Biogen, is indicated for patients with mild cognitive impairment or mild dementia due to Alzheimer disease.
Gestione dell’ictus acuto
Menarini, via libera Fda a farmaco per sottotipo tumore seno
In stato avanzato o metastatico. Prima cura per questa mutazione
Con ddl delega nasce il Sistema nazionale assistenza anziani
Sigot, l’obiettivo è assicurare cure di qualità
Con ddl delega nasce il Sistema nazionale assistenza anziani
Sigot, l’obiettivo è assicurare cure di qualità
FDA Warns of Risks of Body Sculpting
iStock.com/andresr
Use of Recalled Devices in FDA New Device Authorizations and Risk of Subsequent Recalls
This cross-sectional study evaluates the frequency of new devices receiving US Food and Drug Administration approval through its 510(k) pathway based on predicate devices that had been subject to a Class 1 recall.