Drug Approval

Known as: Food and Drug Administration Drug Approval, Approval, Drug, Drug Approvals 
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or… (More)
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
Highly Cited
2012
Highly Cited
2012
n engl j med 366;26 nejm.org june 28, 2012 2438 minority will have hepatocellular carcinoma. Should the decision to treat be… (More)
Is this relevant?
Review
2012
Review
2012
Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is… (More)
  • figure 1
  • figure 2
Is this relevant?
Review
2011
Review
2011
The first decade of the 21st century was a challenging period for the pharma sector and could prove to be a turning point in the… (More)
  • figure 1
  • figure 2
  • figure 3
  • table 1
  • figure 4
Is this relevant?
Review
2009
Review
2009
Historically, the majority of new drugs have been generated from natural products (secondary metabolites) and from compounds… (More)
  • figure 1
  • figure 2
  • figure 3
  • figure 4
Is this relevant?
Highly Cited
2008
Highly Cited
2008
This manuscript summarizes the recommendations of the American Society of Hematology/US Food and Drug Administration Workshop on… (More)
  • table 2
  • table 1
  • table 3
Is this relevant?
Highly Cited
2007
Highly Cited
2007
On October 11, 2006, the U.S. Food and Drug Administration granted approval for bevacizumab (Avastin; Genentech, Inc., South San… (More)
Is this relevant?
Highly Cited
2005
Highly Cited
2005
On November 18, 2004, erlotinib (Tarceva); OSI Pharmaceuticals, Inc., Melville, NY, http://www.osip.com, and Genentech, Inc… (More)
Is this relevant?
Review
2005
Review
2005
On May 19, 2004, azacitidine (5-azacytidine; Vidaza(trade mark); Pharmion Corporation, Boulder, CO, http://www.pharmion.com) for… (More)
Is this relevant?
Highly Cited
2004
Highly Cited
2004
On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States… (More)
  • table 1
  • table 2
  • table 3
  • table 4
  • table 5
Is this relevant?
Highly Cited
2003
Highly Cited
2003
On May 5, 2003, gefitinib (Iressa), ZD1839) 250-mg tablets received accelerated approval by the U.S. Food and Drug Administration… (More)
Is this relevant?