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Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022.
BMC Med
December 2024
Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China.
Background: The Food and Drug Administration (FDA)'s Accelerated Approval (AA) pathway has increasingly used to authorize market approval of new drugs amid controversy. The present study aims to inform the most recent data on the strength of clinical evidence supporting such approvals.
Methods: Evidentiary characteristics of pre-approval pivotal clinical studies and regulator-required post-approval confirmatory studies supporting AAs between 2015 and 2022 were extracted from publicly available FDA documents.
Safety evaluation of targeted osmotic lysis therapy in Beagles.
Am J Vet Res
December 2024
Phantom Laboratory, Greenwich, NY.
Objective: The objective of this study was to satisfy the US FDA's Center for Devices and Radiological Health regarding the safety of targeted osmotic lysis (TOL), a novel treatment for advanced carcinomas, in Beagle dogs.
Methods: 12 intact Beagle dogs, 6 males and 6 females, were divided into 2 treatment groups of 6, each receiving 3 TOL cycles. For each 6-day cycle, digoxin was administered orally at 0.
Navigating regulatory and policy challenges for AI enabled combination devices.
Front Med Technol
November 2024
Advance Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Washington, DC, United States.
In recent years, the Artificial Intelligence (AI) has enabled conventional Combination Devices (CDs) to innovate in healthcare merging with technology sectors. However, the challenges like reliance on predicate devices in US Food and Drug Administration (FDA's 510(k) pathway, especially for perpetually updating AI are stressed. Though the European Union (EU's new Medical Device Regulations address software and AI, fitting adaptive algorithms into conformity assessments remains difficult.
View Article and Find Full Text PDF'Lenmeldy (OTL-200) in MLD: FDA's validation of advanced therapy'.
Ann Med Surg (Lond)
November 2024
Faculty of Medicine, Alzaiem Alazhari University, Khartoum, Sudan.
The opioid industry's use of scientific evidence to advance claims about prescription opioid safety and effectiveness.
Health Aff Sch
October 2024
School of Health, Department of Global Health, Georgetown University, Washington, DC, 20057, United States.
It is widely recognized that pharmaceutical marketing contributed to the ongoing US opioid epidemic, but less is understood about how the opioid industry used scientific evidence to generate product demand, shape opioid regulation, and change clinician behavior. In this qualitative study, we characterize select scientific articles used by industry to support safety and effectiveness claims and use a novel database, the Opioid Industry Documents Archive, to determine notable elements of industry and non-industry documents citing the scientific articles to advance each claim. We found that 15 scientific articles were collectively mentioned in 3666 documents supporting 5 common, inaccurate claims: opioids are effective for treatment of chronic, non-cancer pain; opioids are "rarely" addictive; "pseudo-addiction" is due to inadequate pain management; no opioid dose is too high; and screening tools can identify those at risk of developing addiction.
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