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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.
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… 
2018
2018
CRISPR gene therapy trial on hold
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… 
2014
2014
Synthetic Cannabinoids: Synthesis and Biological Activities
2013
2013
A Generic Problem: Should FDA Approval of Drugs Stop Consumers’ Suits for Injuries?
2010
2010
Reforming Off-Label Promotion to Enhance Orphan Disease Treatment
Allowing off-label promotion by drug companies may improve access to key treatments for orphan disease patients. Once the U.S… 
2007
2007
Gestão do processo de desenvolvimento de novos produtos: o caso Braskem
Atualmente, a competitividade esta fortemente associada a rapida introducao de bens e servicos de alto valor agregado ao mercado… 
2004
2004
[FDA approval for the antidepressive drug Cymbalta].
Review
1997
Review
1997
Integration of research in pharmacotherapy for addictive disease: where are we? Where are we going?
Systematic efforts by NIDA and NIAAA to develop new medications for drug and alcohol dependence have resulted in recent FDA… 
1988
1988
The molecular structure of indium oxine.
The radiopharmaceutical use of [111In]oxine for radiolabeling of blood products has recently met with FDA approval. The molecular… 
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