Definitions for "NEW DRUG APPLICATION"
Related Terms:
Nda, Investigational new drug, Ind , Investigational new drug application, Investigational drug, Ind application, Phase iv, Phase iv trials, Off-label use, Investigational, Anda, Treatment ind, Phase i clinical trial, Phase i, Accelerated approval, Compassionate use, Expanded access, Clinical studies, Phase ii clinical trial, Cta, Dsmb, Investigator's brochure, Phase iii study, Phase iii trials, Phase iib, Double-blind trial, Phase ii, Phase iii, Orphan drug designation, Clinical investigation, Phase iii clinical trial, Clinical trials, Open-label trial, Clinical trial, Drug discovery, Off-label, Data and safety monitoring board, Experimental, Indication, Phase iii trial, Phase i trials, Phase 1, Phase i trial, Placebo-controlled study, Reb, Cmc , Institutional review board, Investigator, Investigational device exemption, Clinical research associate
The New Drug Application contains most of the information included in the IND. Only after FDA approval of the NDA, can distribution and marketing of a new drug begin.
Request for FDA approval to market a new drug.
An application to the FDA for a license to market a new drug in the United States.
Application filed with the Food and Drug Administration to obtain approval to market a prescription drug.
An application made to FDA that requests a license to market a new pharmaceutical in the United States. The application must include all appropriate clinical data from phase I through phase III clinical trials.
an application requesting FDA approval to market interstate commerce a new drug for human use
The vehicle through which drug sponsors formally propose that the U.S. Food and Drug Administration approve a new pharmaceutical for sale and marketing. This application is usually filed once a trial has generated adequate data to support a certain indication for a drug (usually by finding that the drug is safe and superior to standard treatment in a definitive phase III trial). The data gathered during pre-clinical studies as well as manufacturing specifications of an Investigational New Drug are also part of the NDA filing.
is a document submitted to the FDA containing all the pre-clinical and clinical data collected on a drug for approval and eventual marketing.
Application filed by a manufacturer to market a drug in the U.S., contains all known nonclinical, clinical, pharmacological, pharmacokinetic, and stability data about the drug
When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number.
An application requesting FDA approval to market a new drug for human use in interstate commerce. The application must contain, among other things, data from specific technical viewpoints for FDA review--including chemistry, pharmacology, medical, biopharmaceutics, statistics, and, for anti-infectives, microbiology.
The application filed with FDA by the trial sponsor once a trial has generated adequate data to support a certain indication for a drug (usually by finding that the drug is safe and superior to standard treatment in a definitive phase 3 trial).
Request for authorization from the FDA to market a new drug product.
An application submitted by the manufacturer of a drug to the FDA for a license to market the drug for a specific indication. The application is submitted after all phases of clinical trials have been completed.
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.
The compilation of all non-clinical, clinical, pharmacological, pharmacokinetic and stability information required about a drug by the FDA in order to approve the drug for marketing in the U.S.
An NDA is filed for the approval of a new drug product. According to the FDA, the NDA must include "scientific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics." If the NDA is approved, the product may be marketed in the United States.
an application made by a drug manufacturer to FDA requesting marketing approval of a new drug.
is an application to the U.S. Food and Drug Administration (FDA) seeking approval of a new drug that has undergone Phase II and Phase III clinical trials. An NDA is submitted in the form of pages of data, along with various analyses of that data concerning efficacy and safety.
An NDA is an informational petition to the FDA, containing records of all clinical and preclinical investigations and requesting permission to market the drug in the US.
A petition to the FDA for approval to market a drug in the U. S. Manufacturers submit an NDA after Phase III trials have been completed.
an application to the FDA asking for approval to market a new drug.
Sponsors file an NDA with the FDA upon completion of testing, requesting approval to market the drug.
application filed with the FDA Center for Drug Evaluation and Research (CDER) for approval to market a small-molecule drug.
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.