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FDA Approval

A written regulatory communication from FDA to an applicant, who submitted request to the agency to approve marketing or to license medical product… 
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
Review
2019
Review
2019
5-ALA and FDA approval for glioma surgery
The US Food and Drug Administration (FDA) approved 5-aminolevulinic acid (5-ALA; Gleolan®; photonamic GmbH and Co. KG) for use as… 
2018
2018
Flexible FDA Approval Policies 1
  • 2018
  • Corpus ID: 264733040
Since its establishment in 1906, the U.S. Food and Drug Administration (FDA) has approved over 1,500 novel drugs, with total… 
2017
2017
The Long and Winding Road After FDA Approval: A Medical Device Industry Perspective.
> The road is long > > With many a winding turn > > That leads us to who knows where > > Who knows where > > —“He Ain’t… 
Highly Cited
2017
Highly Cited
2017
FDA Approval of Tisagenlecleucel: Promise and Complexities of a $475 000 Cancer Drug.
Approval of the drugtisagenlecleucel(Kymriah;Novartis) by the US Food and Drug Administration (FDA) for the treatment of… 
Review
2015
Review
2015
PRECICE intramedullary limb lengthening system
The PRECICE® Intramedullary Limb Lengthening System (Ellipse Technologies Inc., CA, USA) is a remotely controlled, magnetically… 
2013
2013
A Generic Problem: Should FDA Approval of Drugs Stop Consumers’ Suits for Injuries?
Highly Cited
2010
Highly Cited
2010
The US Orphan Drug Act: rare disease research stimulator or commercial opportunity?
2004
2004
[FDA approval for the antidepressive drug Cymbalta].
Review
2004
Review
2004
Enzyme replacement therapy for Fabry disease: lessons from two α-galactosidase A orphan products and one FDA approval
Two virtually identical products have been developed for enzyme replacement therapy for the treatment of Fabry disease, which is… 
Review
2000
Review
2000
Progress in antisense technology: the end of the beginning.
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