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Humanitarian Device Exemption

Known as: Humanitarian Device Exemptions, Exemption, Humanitarian Device, Device Exemptions, Humanitarian 
A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals… 
National Institutes of Health

Related topics

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Compassionate Use TrialsStructured Product Labeling Marketing Category Terminology

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
Review
2013
Review
2013
CFHTLenS: the environmental dependence of galaxy halo masses from weak lensing
We use weak gravitational lensing to analyse the dark matter haloes around satellite galaxies in galaxy groups in the Canada… 
2010
2010
Identification of rat urinary metabolites of rifabutin using LC-MSn and LC-HR-MS.
2006
2006
Allergens induce enhanced bronchoconstriction and leukotriene production in C5 deficient mice
BackgroundPrevious genetic analysis has shown that a deletion in the complement component 5 gene-coding region renders mice more… 
2005
2005
Optimal multiobjective planning of large-scale passive harmonic filters using hybrid differential evolution method considering parameter and loading uncertainty
This paper is used to investigate the optimal multiobjective planning of large-scale passive harmonic filters for a multibus… 
Highly Cited
2001
Highly Cited
2001
Eotaxin Represents the Principal Eosinophil Chemoattractant in a Novel Murine Asthma Model Induced by House Dust Containing Cockroach Allergens1
Asthma represents a serious health problem particularly for inner city children, and recent studies have identified that… 
Highly Cited
1996
Highly Cited
1996
A hybrid clinical-research depth electrode for acute and chronic in vivo microelectrode recording of human brain neurons. Technical note.
For several decades, important scientific information has been gained from in vivo microelectrode recordings of individual human… 
1996
1996
Length suppression in histone messenger RNA 3'-end maturation: processing defects of insertion mutant premessenger RNAs can be compensated by insertions into the U7 small nuclear RNA.
Efficient 3'-end processing of cell cycle-regulated mammalian histone premessenger RNAs (pre-mRNAs) requires an upstream stem… 
Highly Cited
1995
Highly Cited
1995
Comparative Pulmonary Toxicities and Carcinogenicities of Chronically Inhaled Diesel Exhaust and Carban Black in F344 Rats
Abstract Diesel exhaust (DE) is a known pulmonary carcinogen in rats, and the carcinogenic response is known to require the… 
1994
1994
Pulsed field gradient spin-echo NMR measurement of water diffusion coefficient in thickening and gelling agents: guar galactomannan solutions and pectin gels.
The Pulsed Field Gradient Spin-Echo (PFG-SE) method was used to study the diffusional properties of water in guar galactomannan… 
Highly Cited
1988
Highly Cited
1988
cDNA cloning and primary structure determination of the peroxisomal trifunctional enzyme hydratase-dehydrogenase-epimerase from the yeast Candida tropicalis pK233.
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