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 ?
The FDA New Drug Application is specifically for the use of the agent to detect tumors that originate from neuro-endocrine cells, found primarily in the abdominal area of the body.
Lee was responsible for study design, and protocol preparation of Phase I and Phase II a trials, and helped develop and implement regulatory strategies related to new drug development and operations for Investigative New Drug and New Drug Application submissions to the FDA.
Food and Drug Administration of a new drug application for DBD.
The Company intends to broaden PMI-150's potential initial label as an analgesic for emergency use with future Supplemental New Drug Applications (sNDAs) to increase patient access to the product after initial approval, contingent upon suitable risk assessment.
BioSante submitted the Bio-E-Gel new drug application (NDA) in February 2006.
Hatch-Waxman Act and Procedure: new drug application (NDA); abbreviated new drug application (ANDA); paragraph I, II, III, and IV certifications; authorized generics; and the 180-day incentive.
Successful completion of development efforts are anticipated to result in the Company's filing of an Abbreviated New Drug Application (ANDA) with the FDA.
Submission of the New Drug Application for TOCOSOL Paclitaxel is expected by the end of 2007.