Results 91 to 100 of about 687,018 (362)

Public feedback to FDA on regulatory considerations for AI in drug manufacturing

AAPS Open
FDA’s Center for Drug Evaluation and Research (CDER) established the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to establish a regulatory framework to support the adoption of advanced manufacturing technologies that ...
Jayanti Das, Thomas F. O’Connor, Adam C. Fisher, Manuel Osorio, Johnny Lam, Riley C. Myers   +5 more
doaj   +1 more source

Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?

Clinical pharmacology and therapy, 2019
There is talk of regulatory collaboration worldwide to protect public health and allow patients timely access to medicines. Here, we present the reality of the collaboration between the European Medicines Agency (EMA) and the US Food and Drug ...
T. Teixeira, S. Kweder, A. Saint‐Raymond   +2 more
semanticscholar   +1 more source

Functional parameters of spermatozoa obtained by a new selection device

FEBS Open Bio, EarlyView.
This study compares density gradient centrifugation and the LensHooke CA0™ device for sperm separation. DGC requires multiple steps, specialized equipment, and technical expertise. In contrast, the CA0 device offers key practical and methodological advantages, resulting in a faster, simpler, and more affordable sperm selection method.
Julio C. Chávez, Paulina Torres, Gabriela Carrasquel‐Martínez, María G. Figueroa‐Méndez, Diana Flores, Lina Villar, Israel Maldonado, Marcela B. Trevino, Claudia Treviño   +8 more
wiley   +1 more source

Additively manufactured medical products – the FDA perspective

3D Printing in Medicine, 2016
Additive manufacturing/3D printing of medical devices is becoming more commonplace, a 3D printed drug is now commercially available, and bioprinting is poised to transition from laboratory to market.
Matthew Di Prima, James Coburn, David Hwang, Jennifer Kelly, Akm Khairuzzaman, Laura Ricles   +5 more
doaj   +1 more source

Plastic Surgeons Defend Textured Breast Implants at 2019 U.S. Food and Drug Administration Hearing: Why It Is Time to Reconsider

Plastic and Reconstructive Surgery, Global Open, 2019
Summary Textured breast implants were the subject of a U.S. Food and Drug Administration (FDA) hearing on March 25 and 26, 2019. Regulating agencies in other countries, including all of Europe and Canada, have already banned macrotextured implants ...
E. Swanson
semanticscholar   +1 more source

Polydatin ameliorates ovalbumin‐induced asthma in a rat model through NCOA4‐mediated ferroautophagy and ferroptosis pathway

FEBS Open Bio, EarlyView.
In this research, a rat model of asthma was created using OVA, and polydatin served as an intervention. By inhibiting ferroautophagy mediated by NCOA4 and averting ferroptosis, polydatin has been demonstrated to reduce asthma. This work presents new ideas for investigating the mechanism of polydatin's ability to alleviate asthma, in addition to ...
Wei Li, Yuwei Tang, Wenkang Liu, Fang Fang, Jiepeng Wang, Chaoyi Fang   +5 more
wiley   +1 more source

Amyotrophic Lateral Sclerosis as a Multistep Process in the United States: A Population‐Based Study

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Background Amyotrophic lateral sclerosis (ALS) is a fatal, progressive neurodegenerative disease that typically results in death within 3–5 years from symptom onset. However, little is known about the environmental exposures, clinical aspects, or social determinants of health factors that may be associated with the disease.
Jasmine Berry, Jaime Raymond, Theodore Larson, D. Kevin Horton, Moon Han, Theresa Nair, Ammar Al‐Chalabi, Paul Mehta   +7 more
wiley   +1 more source

BCS1L‐Associated Disease: 5′‐UTR Variant Shifts the Phenotype Towards Axonal Neuropathy

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objectives To investigate the consequences of a pathogenic missense variant (c.838C>T; p.L280F) and a 5′‐UTR regulatory variant (c.‐122G>T) in BCS1L on disease pathogenesis and to understand how regulatory variants influence disease severity and clinical presentation.
Rotem Orbach, Nunziata Maio, Russell J. Butterfield, A. Reghan Foley, Sarah Silverstein, Yan Li, Katherine Chao, Tanya J. Lehky, Abigail Potticary, Tracey A. Rouault, Sandra Donkervoort, Carsten G. Bönnemann   +11 more
wiley   +1 more source

Use of data mining at the Food and Drug Administration

J. Am. Medical Informatics Assoc., 2016
OBJECTIVES This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA). TARGET AUDIENCE We address data miners in all sectors, anyone interested in the safety of products regulated by the FDA (
H. Duggirala, Joseph M. Tonning, Ella S Smith, R. Bright, J. Baker, R. Ball, Carlos Bell, S. Bright-Ponte, Taxiarchis Botsis, Khaled Bouri, M. Boyer, K. Burkhart, G. S. Condrey, James J. Chen, S. Chirtel, Ross W. Filice, H. Francis, Hongying Jiang, Jonathan G. Levine, David Martin, T. Oladipo, Rene O'Neill, L. A. Palmer, Antonio Paredes, George Rochester, D. Sholtes, A. Szarfman, H. Wong, Zhiheng Xu, Taha A. Kass-Hout   +29 more
semanticscholar   +1 more source

Effects of Pharmacologic and Nonpharmacologic Interventions for the Management of Sleep Problems in People With Fibromyalgia: Systematic Review and Network Meta‐Analysis of Randomized Controlled Trials

Arthritis Care &Research, EarlyView.
Objective Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain and fatigue. Almost everyone with fibromyalgia has sleep problems. We aimed to evaluate the effectiveness and safety of current interventions for the management of fibromyalgia‐related sleep problems.
Jemma Hudson, Mari Imamura, Clare Robertson, Daniel Whibley, Lorna Aucott, Katie Gillies, Paul Manson, Debra Dulake, Abhishek Abhishek, Nicole K. Y. Tang, Gary J. Macfarlane, Miriam Brazzelli   +11 more
wiley   +1 more source