Results 11 to 20 of about 690,240 (260)

Will Consumers be in the Dark about Labels on Genetically Engineered and Modified Foods? [PDF]

, 2021
In the 1900s, the United States began to sell genetically engineered foods. One of the first genetically engineered foods sold in the United States and approved by the Food and Drug Administration (FDA) was the Flavr Savr tomato.
Nat, Hilary
core   +1 more source

Through the looking glass: understanding non-inferiority [PDF]

, 2011
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United ...
BL Wiens, DB Petitti, EMA Committee for Medicinal Products for Human Use (CHMP), EMA Committee for Proprietary Medicinal Products (CPMP), J Wittes, Janet T Wittes, Jennifer Schumi, KK Teo, M Rothmann, MD Rothmann, N Mantel, R DerSimonian, R Temple, S Snappin, S Snappin, S Yusuf, SS Ellenberg, TR Fleming, TR Fleming, United States Food and Drug Administration   +19 more
core   +3 more sources

Influence of dimethyl dicarbonate on the resistance of Escherichia coli to a combined UV-Heat treatment in apple juice [PDF]

, 2015
Commercial apple juice inoculated with Escherichia coli was treated with UV-C, heat (55°C) and dimethyl dicarbonate – DMDC (25, 50, and 75 mg/L)-, applied separately and in combination, in order to investigate the possibility of synergistic lethal ...
AIJN, Bartowsky, Basaran, Basaran-Akgul, Besser, Char, Cody, Condón, Costa, Daudt, Delfini, Fisher, Franz, Gachovska, Gayán, Gayán, Gayán, Gayán, Gayán, Geveke, Gouma, Guerrero-Beltrán, Halim, Koivunen, Koutchma, Koutchma, Koutchma, López-Malo, Murakami, Müller, National Advisory Committee on Microbiological Criteria for Foods of the United States Department of Agriculture [NACMCF]., Parikh, Porter, Quicho, Quintero-Ramos, Sastry, United States Food and Drug Administration [USFDA]., United States Food and Drug Administration [USFDA]., United States Food and Drug Administration [USFDA]., Vojdani, Wright, Wu, Yu   +42 more
core   +3 more sources

TOMM20 as a driver of cancer aggressiveness via oxidative phosphorylation, maintenance of a reduced state, and resistance to apoptosis

Molecular Oncology, EarlyView.
TOMM20 increases cancer aggressiveness by maintaining a reduced state with increased NADH and NADPH levels, oxidative phosphorylation (OXPHOS), and apoptosis resistance while reducing reactive oxygen species (ROS) levels. Conversely, CRISPR‐Cas9 knockdown of TOMM20 alters these cancer‐aggressive traits.
Ranakul Islam, Megan E. Roche, Zhao Lin, Diana Whitaker‐Menezes, Victor Diaz‐Barros, Eurico Serrano, Maria Paula Martinez Cantarin, Nancy J. Philp, Atrayee Basu Mallick, Ubaldo Martinez‐Outschoorn   +9 more
wiley   +1 more source

"The United States Food and Drug Administration: Its role, authority, history, harmonization activities, and cooperation with the European Union." [PDF]

, 1997
The purpose of this article is to provide background about the United States Food and Drug Administration (FDA). The article will focus particularly upon the agency's authority, its place in the United States system, and its history as a domestic ...
Horton, Linda.
core  

FDA Medical Device Warning Letters and Trends Pre and Post COVID 2013-2022 [PDF]

, 2023
© 2023 Anderson R, et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY), https://creativecommons.org/licenses/by/4.0/The United States Food & Drug Administration requires under Title 21 of ...
Anderson, Randy, Tan, Christabel
core   +1 more source

Enhancing patient engagement in cancer research: a focus on patient‐centric approaches to scientific discovery

Molecular Oncology, EarlyView.
Patient engagement involves actively including patients in healthcare decisions and research to ensure care and studies align with their needs. This approach improves outcomes, trust, and communication while fostering collaboration between patients and professionals.
Estela Cepeda, Marina Reguero, Vanesa Abón, Marta Puyol   +3 more
wiley   +1 more source

System Safety In The News [PDF]

, 2019
FDA Shuts Down Program that Allowed Medical Device Makers to Hide Reports of Malfunctions The United States Food and Drug Administration (FDA) recently announced that it is ending a decadeslong program that allowed medical device manufacturers to conceal
Muniak, Charles
core   +2 more sources

Targeting the AKT/mTOR pathway attenuates the metastatic potential of colorectal carcinoma circulating tumor cells in a murine xenotransplantation model

Molecular Oncology, EarlyView.
Dual targeting of AKT and mTOR using MK2206 and RAD001 reduces tumor burden in an intracardiac colon cancer circulating tumor cell xenotransplantation model. Analysis of AKT isoform‐specific knockdowns in CTC‐MCC‐41 reveals differentially regulated proteins and phospho‐proteins by liquid chromatography coupled mass spectrometry. Circulating tumor cells
Daniel J. Smit, Thais Pereira‐Veiga, Helena Brauer, Michael Horn, Paula Nissen, Thomas Mair, Bente Siebels, Hannah Voß, Ruimeng Zhuang, Marie‐Therese Haider, Desiree Loreth, Margarita Iskhakova, Bele Lindemann, Julian Kött, Laure Cayrefourcq, Jasmin Wellbrock, Hartmut Schlüter, Klaus Pantel, Catherine Alix‐Panabières, Manfred Jücker   +19 more
wiley   +1 more source

Molecular imaging predicts trastuzumab‐deruxtecan (T‐DXd) response in head and neck cancer xenograft models

Molecular Oncology, EarlyView.
Trastuzumab‐deruxtecan, a HER2‐targeting antibody‐drug conjugate, shows promising antitumor activity in head and neck squamous cell carcinoma with low HER2 expression. In vitro and in vivo studies demonstrated dose‐dependent cell death and tumor growth reduction in low HER2‐expressing cell lines, which correlated with drug accumulation measured using a
Abdullah Bin Naveed, Lucas Mani, Muhammad Bilal Mirza, Ashtyn McAdoo, Takahito Kondo, Hidenori Tanaka, Nicole Meeks, Eben Rosenthal, Marisa Hom   +8 more
wiley   +1 more source