new drug application


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Related to new drug application: abbreviated new drug application

New Drug Application (NDA),

a document whereby a pharmaceutical manufacturer or its agent requests permission from the United States Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications; besides a chemical and pharmacologic description of the drug, the application must show the results of clinical trials conducted with respect to the indication for which a license is requested.

New Drug Application

EBM
An application to FDA for a licence to market a new drug in the USA.

new drug application

See NDA.

new drug application

,

NDA

An application requiring approval by the Food and Drug Administration before any new drug is marketed to the general public. Before approval, the manufacturer must provide the FDA with scientifically acceptable evidence of the new drug's safety and efficacy.
References in periodicals archive ?
According to the available information, Actavis believes it may be a 'first applicant' to file an Abbreviated New Drug Application for the generic version of Absorica(r), and, should its Abbreviated New Drug Application be approved, may be entitled to 180 days of generic market exclusivity.
Its products are used by pharmaceutical, biotechnology and medical device companies to create new drug applications, reports, proposals and technical documentation.
IHI president/ceo Mason Slaine said that IHI "now has the most complete suite of offerings related to new drug applications (NDAs) of any company in the world.
M2 EQUITYBITES-August 22, 2014-Lannett signs contract to acquire abbreviated new drug applications for two generic pharmaceutical products
M2 PHARMA-August 22, 2014-Lannett signs contract to acquire abbreviated new drug applications for two generic pharmaceutical products