NEW DRUG APPLICATION. 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.
NEW DRUG APPLICATION. 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.
(New Drug Application) Application to the FDA requesting approval to market a new drug
New Drug Application. 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.
New Drug Application. 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.
New Drug Application, the vehicle through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing in the U.S.
see new drug application.
new drug application. an application made by a drug manufacturer to FDA requesting marketing approval of a new drug.
New Drug Application. 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.
New Drug Application. Request for FDA approval to market a new drug.
New Drug Application. 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.
New Drug Application. A comprehensive compilation of the documentation used to support the safe and effective used of a drug.
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.
New Drug Application. 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.
new drug application; filed with the FDA after clinical trials are successfully completed
New Drug Application. 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.
New Drug Application. an application to the FDA asking for approval to market a new drug.
(from www.gmp1st.com/drglos). New Drug Application
New Drug Approval application. Granted with successful completion of phase I - III clinical trials for an investigational prescription drug. Clears the way for phase IV drug study.
New drug application. 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.
New Drug Application (must be submitted to the FDA for approval to manufacture and market the drug.
New Drug Application. Sponsors file an NDA with the FDA upon completion of testing, requesting approval to market the drug.
New Drug Application. application filed with the FDA Center for Drug Evaluation and Research (CDER) for approval to market a small-molecule drug.
New Drug Application made to a regulatory agency.
new drug application. An application to FDA for a license to market a new drug in the United States.
New Drug Application, a complete application (typically thousands of pages long) to the FDA (Food and Drug Administration) to begin marketing of a drug product in the US.
New Drug Application. A large document that contains all required data on the safety and efficacy of a new drug product. The NDA must be submitted to the FDA for approval before the product can be sold in the U.S.
New Drug Application. 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
New Drug Application. 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).
New Drug Application. The process used to request marketing approval for a potential new drug from the U.S. Food and Drug Administration.
New Drug Application. 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 an 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.
A large document that is filed with the United States Food and Drug Administration (FDA) requesting approval for a proposed therapy. This document is filed once all clinical testing is completed and results have been analyzed. It contains all of the information relating to the proposed drug, including adverse events and details on the manufacturing process.
New Drug Application, a document containing all preclinical, clinical and chemistry, manufacturing and control data collected on a drug. An NDA is submitted to the FDA in order to obtain approval to market a prescription drug in the United States.
