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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]
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
Analysing musical performance through functional data analysis: rhythmic structure in Schumann's Träumerei [PDF]
Functional data analysis (FDA) is a relatively new branch of statistics devoted to describing and modelling data that are complete functions. Many relevant aspects of musical performance and perception can be understood and quantified as dynamic ...
Almansa, J+1 more
core +2 more sources
Surfaceome: a new era in the discovery of immune evasion mechanisms of circulating tumor cells
In the era of immunotherapies, many patients either do not respond or eventually develop resistance. We propose to pave the way for proteomic analysis of surface‐expressed proteins called surfaceome, of circulating tumor cells. This approach seeks to identify immune evasion mechanisms and discover potential therapeutic targets. Circulating tumor cells (
Doryan Masmoudi+3 more
wiley +1 more source
Neonates and young infants are known to have limited responses to pediatric vaccines due to reduced germinal center formation. Extended vaccine antigen dosing was previously shown to expand germinal center formation and improve humoral responses in adult
Leda Lotspeich-Cole+6 more
doaj +1 more source
A review of hospital based ventilator malfunctions reported to the FDA in 2021
Ventilator care is synonymous with Intensive care. These devices are electromechanical and as such can fail. Most failures are without patient incident, injury, and harm.
Stephen Tunnell
doaj +1 more source
[Excerpt] The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice.
Cohen, I. Glenn, Price, W. Nicholson, II
core +1 more source
Circulating tumor DNA (ctDNA) offers a possibility for different applications in early and late stage breast cancer management. In early breast cancer tumor informed approaches are increasingly used for detecting molecular residual disease (MRD) and early recurrence. In advanced stage, ctDNA provides a possibility for monitoring disease progression and
Eva Valentina Klocker+14 more
wiley +1 more source
Circulating tumor cells: advancing personalized therapy in small cell lung cancer patients
Small cell lung cancer (SCLC) is an aggressive form of lung cancer that spreads rapidly to secondary sites such as the brain and liver. Cancer cells circulating in the blood, “circulating tumor cells” (CTCs), have demonstrated prognostic value in SCLC, and evaluating biomarkers on CTCs could guide treatment decisions such as for PARP inhibitors ...
Prajwol Shrestha+6 more
wiley +1 more source
Enhancing Functional Data Analysis with Sequential Neural Networks: Advantages and Comparative Study [PDF]
Functional Data Analysis (FDA) is a statistical domain developed to handle functional data characterized by high dimensionality and complex data structures. Sequential Neural Networks (SNNs) are specialized neural networks capable of processing sequence data, a fundamental aspect of functional data.
arxiv