Results 41 to 50 of about 1,107,201 (376)

Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research

Frontiers in Medicine, 2017
Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration’s ...
Marc Kusinitz, Emily Braunstein, Carolyn A. Wilson   +2 more
doaj   +1 more source

An Insight into FDA Approved Antibody-Drug Conjugates for Cancer Therapy

Molecules, 2021
The large number of emerging antibody-drug conjugates (ADCs) for cancer therapy has resulted in a significant market ‘boom’, garnering worldwide attention.
Juliana T W Tong, P. Harris, M. Brimble, I. Kavianinia   +3 more
semanticscholar   +1 more source

Antibody affinity maturation and plasma IgA associate with clinical outcome in hospitalized COVID-19 patients

Nature Communications, 2021
SARS-CoV2 infection has been linked to a wide range of clinical severities and the immunopathology is still under intense scrutiny. Here, the authors uncover an association of antibody affinity maturation and plasma IgA levels with clinical outcome in ...
Juanjie Tang, Supriya Ravichandran, Youri Lee, Gabrielle Grubbs, Elizabeth M. Coyle, Laura Klenow, Hollie Genser, Hana Golding, Surender Khurana   +8 more
doaj   +1 more source

Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. [PDF]

, 2008
BackgroundPrevious studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results.
Bacchetti, Peter, Bero, Lisa, Rising, Kristin   +2 more
core   +3 more sources

FDA-Approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: An Updated Landscape

Electronics
As artificial intelligence (AI) has been highly advancing in the last decade, machine learning (ML)-enabled medical devices are increasingly used in healthcare.
Geeta Joshi, Aditi Jain, Shalini Reddy Araveeti, Sabina Adhikari, Harshit Garg, Mukund Bhandari   +5 more
semanticscholar   +1 more source

Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products [PDF]

, 2005
Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind\u27s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes
Bergman, Karl-Olof, Milberg, Per, Wikstroem, Linnea   +2 more
core   +3 more sources

Pure Spinors, Free Differential Algebras, and the Supermembrane [PDF]

, 2006
The lagrangian formalism for the supermembrane in any 11d supergravity background is constructed in the pure spinor framework. Our gauge-fixed action is manifestly BRST, supersymmetric, and 3d Lorentz invariant. The relation between the Free Differential
Aisaka, Aisaka, Anguelova, Anguelova, Anselmi, Bandos, Bandos, Bars, Bars, Baulieu, Bergshoeff, Bergshoeff, Bergshoeff, Berkovits, Berkovits, Berkovits, Berkovits, Billo, Castellani, Castellani, Castellani, Castellani, Castellani, Castellani, Castellani, D'Auria, Dall'Agata, de Wit, Duff, Duff, Duff, Duff, Fre, Fré, Fré, Fré, Goto, Grassi, Grassi, Grassi, Grassi, Grassi, Green, Green, Harvey, Hatsuda, Mafra, Matone, Oda, Pesando, Pietro Antonio Grassi, Pietro Fré, Plefka, Polyakov, Sullivan, Tonin   +55 more
core   +2 more sources

FDA-Approved Trifluoromethyl Group-Containing Drugs: A Review of 20 Years

Processes, 2022
As people around the world regard 2020 as the year of COVID-19, the medical community considers this year to be the second-best year, shared with the year 1996, with respect to the number of drug molecules approved by the US Food and Drug Administration (
Aathira S. Nair, Ashutosh Kumar Singh, Astik Kumar, S. Sushanth Kumar, S. Sukumaran, V. P. Koyiparambath, L. K. Pappachen, T. Rangarajan, Hoon Kim, B. Mathew   +9 more
semanticscholar   +1 more source

FDA-Approved and Emerging Next Generation Predictive Biomarkers for Immune Checkpoint Inhibitors in Cancer Patients

Frontiers in Oncology, 2021
A patient’s response to immune checkpoint inhibitors (ICIs) is a complex quantitative trait, and determined by multiple intrinsic and extrinsic factors.
Ye Wang, Zhuang Tong, Wenhua Zhang, Weizhen Zhang, A. Buzdin, Xiaofeng Mu, Qing Yan, Xiaowen Zhao, Hui-Hua Chang, Mark Duhon, Xin Zhou, Gexin Zhao, Hong Chen, Xinmin Li   +13 more
semanticscholar   +1 more source

Analyzing FDA's approaches to using electronic health record and medical claims data to support regulatory decision making

Реальная клиническая практика: данные и доказательства, 2023
In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions.
Ksenia S. Radaeva, M. V. Pchelintsev
doaj   +1 more source