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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… 
National Institutes of Health

Related topics

Related topics

6 relations
Clinical TrialsInvestigational New DrugsOff-Label Treatmentlegislation & jurisprudence

Broader (1)

Drug Approval Process

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New Drug Approval

Papers overview

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Highly Cited
2013
Highly Cited
2013
'Basket studies' will hold intricate data for cancer drug approvals
The notion of targeting specific cellular mutations to make malignancies disappear got a boost in April when the director of the… 
2010
2010
Fresh from the biologic pipeline—2009
Human antibodies take center stage, as they pile up in the list of approved biologics in 2009. Cormac Sheridan reports. 
Review
2007
Review
2007
The research on community consultation: an annotated bibliography.
Community consultation is a required element of research studies that use a waiver of or exception from informed consent. Its… 
Highly Cited
2006
Highly Cited
2006
The second wave in kinase cancer drugs
Cancer drugs targeting signaling pathways have been hampered by problems of efficacy and tumor resistance. Will the next… 
2005
2005
A state of ignorance
The current US system for checking the safety of drugs already on the market is toothless. Why isn't the government doing more to… 
2005
2005
Could It Happen Again?: The Björk-Shiley Convexo-Concave Heart Valve Story
2002
2002
Neither Moore nor the Market: Alternative Models for Compensating Contributors of Human Tissue
Parts and products of the human body are increasingly important to biomedical research. Tumors removed in surgery help… 
Highly Cited
2001
Highly Cited
2001
Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.
Review
2000
Review
2000
Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias.
Highly Cited
1993
Highly Cited
1993
CD4+ Lymphocytes Are an Incomplete Surrogate Marker for Clinical Progression in Persons with Asymptomatic HIV Infection Taking Zidovudine
Identifying a valid surrogate end point for serious clinical events associated with human immunodeficiency virus (HIV) infection… 
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