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7623. FDA Regulation and Approval of Medical Devices: 1976-2020.
US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation.
7640. Effect of Systemic Hydrocortisone Initiated 7 to 14 Days After Birth in Ventilated Preterm Infants on Mortality and Neurodevelopment at 2 Years' Corrected Age: Follow-up of a Randomized Clinical Trial.
作者: Nienke M Halbmeijer.;Wes Onland.;Filip Cools.;Renate Swarte.;Marja van der Heide-Jalving.;Maruschka P Merkus.;Anton H van Kaam.; .
来源: JAMA. 2021年326卷4期355-357页
This follow-up to the STOP-BPD randomized clinical trial, which investigated the efficacy and safety of systemic hydrocortisone treatment initiated 7 to 14 days after birth in ventilator-dependent, very preterm infants in the Netherlands and Belgium at 36 weeks’ postmenstrual age, examines the prespecified composite of death and neurodevelopmental impairment among these infants at 2 years’ corrected age.
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