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Use of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA's Office of Study Integrity and Surveillance (OSIS) Perspective.
AAPS PharmSciTech
January 2025
OSIS, Silver Spring, Maryland, U.S.A.
Travel restrictions during the novel coronavirus, SARS-CoV-2 (COVID-19) public health emergency affected the U.S. Food and Drug Administration's (FDA) ability to conduct on-site bioavailability/bioequivalence (BA/BE) and Good Laboratory Practice (GLP) nonclinical inspections.
View Article and Find Full Text PDFExposure to a Titanium Dioxide Product Alters DNA Methylation in Human Cells.
Nanomaterials (Basel)
December 2024
Division of Biochemical Toxicity, FDA/National Center for Toxicological Research, Jefferson, AR 72079, USA.
The safety of titanium dioxide (TiO), widely used in foods and personal care products, has been of ongoing concern. Significant toxicity of TiO has been reported, suggesting a risk to human health. To evaluate its potential epigenotoxicity, the effect of exposure to a TiO product to which humans could be exposed on DNA methylation, a primary epigenetic mechanism, was investigated using two human cell lines (Caco-2 (colorectal) and HepG2 (liver)) relevant to human exposure.
View Article and Find Full Text PDFIs Duchenne gene therapy a suitable treatment despite its immunogenic class effect?
Expert Opin Drug Saf
December 2024
Medical Genetics, University of Alberta, Edmonton, Alberta, Canada.
Introduction: Duchenne muscular dystrophy (DMD) is a severe X-linked disorder characterized by progressive muscle weakness and eventual death due to cardiomyopathy or respiratory complications. Currently, there is no cure for DMD, with standard treatments primarily focusing on symptom management. Using immunosuppressive measures and optimized vector designs allows for gene therapies to better address the genetic cause of the disease.
View Article and Find Full Text PDFStrength 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.
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.
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