Results 41 to 50 of about 1,036,661 (382)

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

open access: yesFrontiers 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   +2 more
doaj   +1 more source

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

open access: yesFrontiers 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   +13 more
semanticscholar   +1 more source

The Trade-off between Impartiality and Freedom in the 21st Century Cures Act

open access: yesPhilosophy of Medicine, 2021
Randomized controlled trials test new drugs using various debiasing devices to prevent participants from manipulating the trials. But participants often dislike controls, arguing that they impose a paternalist constraint on their legitimate preferences ...
David Fraile Navarro   +2 more
doaj   +1 more source

Development of a sensitive and rapid method for the measurement of total microbial activity using fluorescein diacetate (FDA) in a range of soils [PDF]

open access: yes, 2001
Fluorescein diacetate (FDA) hydrolysis is widely accepted as an accurate and simple method for measuring total microbial activity in a range of environmental samples, including soils.
Battin   +19 more
core   +1 more source

FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors

open access: yesClinical Cancer Research, 2019
The FDA approved pembrolizumab on May 23, 2017, for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR) solid tumors that have progressed following ...
L. Marcus   +3 more
semanticscholar   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

open access: yes, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

The role of PD-L1 expression as a predictive biomarker: an analysis of all US Food and Drug Administration (FDA) approvals of immune checkpoint inhibitors

open access: yesJournal of Immunotherapy for Cancer, 2019
The development of immune checkpoint inhibitors has changed the treatment paradigm for advanced cancers across many tumor types. Despite encouraging and sometimes durable responses in a subset of patients, most patients do not respond.
A. Davis, V. Patel
semanticscholar   +1 more source

Rewriting the dendritic cell code in cancer—from subset identity to immunotherapeutic design

open access: yesFEBS Letters, EarlyView.
Dendritic cells (DCs) play central roles in cancer immunity but are often subverted by the tumor microenvironment. This review explores the diversity of DC subsets, their functional plasticity, and emerging therapeutic strategies to reprogram DCs for enhanced antitumor responses, including vaccines, in vivo targeting, and DC‐based immunotherapies ...
Estevão Carlos Silva Barcelos   +3 more
wiley   +1 more source

Orphanage at the FDA [PDF]

open access: yesJournal of Cardiovascular Translational Research, 2010
In the late 1970s and early 1980s, social and political forces gave birth to a new movement to serve the needs of people with rare diseases, a movement that has only accelerated with the penetrance of internet connectivity. The FDA's Office of Orphan Products Development (OOPD) was established in 1982 to promote the development of products that ...
openaire   +3 more sources

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes [PDF]

open access: yes, 2005
Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this
Lavender, Mark
core   +1 more source

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