US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021.
Sign Up to like & getrecommendations! Published in 2023 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2022.6444
Abstract: This cross-sectional study determines the frequency of and rationale for US Food and Drug Administration (FDA) approval of drugs not meeting pivotal trial primary efficacy end points. read more here.
Keywords: drugs meeting; meeting pivotal; food drug; drug administration ... See more keywords
Evaluation of a transparent perfluorodecalin‐infused patch as an adjunct to laser‐assisted tattoo removal: A pivotal trial
Sign Up to like & getrecommendations! Published in 2017 at "Lasers in Surgery and Medicine"
DOI: 10.1002/lsm.22659
Abstract: Laser‐assisted treatment of tattoos is well recognized to produce opaque epidermal whitening that prevents multiple sequential passes during a single treatment session. The amount of epidermal whitening produced in association with the procedure can be… read more here.
Keywords: laser; treatment; laser assisted; perfluorodecalin ... See more keywords
PIVOTAL trial: iron loading improves clinical outcomes
Sign Up to like & getrecommendations! Published in 2019 at "Nature Reviews Nephrology"
DOI: 10.1038/s41581-019-0128-5
Abstract: The PIVOTAL trial shows that proactive intravenous (i.v.) iron administration reduces cardiovascular events and deaths, transfusions and erythropoiesis-stimulating agent doses and does not increase infections in patients on haemodialysis. These findings upend the warnings of… read more here.
Keywords: loading improves; iron loading; trial iron; iron ... See more keywords