New drug application: Difference between revisions
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A new drug application (NDA) is an application submitted by the manufacturer of a drug to the FDA - after [[clinical trials]] have been completed - for a license to market the drug for a specified indication. | A new drug application (NDA) is an application submitted by the manufacturer of a drug to the FDA - after [[clinical trials]] have been completed - for a license to market the drug for a specified indication. | ||
[[Category:Jargon]] | |||
Revision as of 20:33, 6 August 2009
A new drug application (NDA) is an application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.