New drug application filing

IND Investigational New Drug application, filed with FDA after preclinical testing is complete asking for permission to proceed with human tests. 

APPLICATION FOR MARKETING AUTHORIZATION shall mean (a) in the United States a new drug application filed with the FDA pursuant to 21 U.S.C. Section 357 and 21 C.F.R. Section 314 ( NDA ) with respect to the Product and (b) in any country other than the United States, an equivalent application or set of applications for marketing approval comparable to an NDA necessary to make and sell Product commercially in such country. 

LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS <21 CFR Pan 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (S CFR Part 3U). DRUG MASTER FILES (2i CFR Pan 314.420A AND PRODUCT LICENSE APPLICATIONS <21 CFR Part 601) REFERRED TO IN THIS APPLICATION. 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

The file may be queried In response to questions from clinical staff at the National Institutes of Health and physlr-clans and laboratory scientists throughout the country who submit their problems by letter or telephone The file has been used to provide Information for a pharmaceutical manufacturing company preparing a new drug application to the Food and Drug Administration For the latter organlzatloi the file has been... 

Salmeterol is also available in a fixed ratio combination product containing fluticasone, and a new drug application has been filed for a fixed combination product containing budesonide and formoterol. Combination products have the potential advantage of increasing patient adherence due to the decreased number of inhalers and inhalations however, these products offer less flexibility with respect to dosage adjustments when necessary. 

This guidance document describes how a New Drug Application (NDA) may be sent electronically to the FDA. The guidance defines how the files in the electronic submission should be structured for FDA review. 

On completion of phase III trials, the data will be checked to see that it fulfils all the criteria required to generate a viable, marketable drag. The company will then file a New Drug Application (NDA), with the intention of proving the efficacy and safety of the drug in this therapeutic application. The NDA will contain all the clinical data and all relevant preclinical data for review by the FDA. Application reviews were 16.2 months on average in 1997 [75]. 

Drug Master Files Investigational New Drug Application New Drug Application... 

For new drug products with little or no effective patent life, generic firms are prohibited from filing an abbreviated new drug application within the first 5 years of the product life. Most European countries prohibit such filing within the first 10 years of market life. 

Pursuant to the Federal Food, Drug, and Cosmetic Act, a brand-name company seeking to market a new dmg produet must first obtain FDA approval by filing a New Drug Application (NDA). The NDA ultimately must include a variety of information that is extremely expensive and time-consuming to develop, including clinical trial data. 

The term Brand-Name Company means each person or company (including its predecessors in interest, subsidiaries, affiliates, successors, and assigns) that has filed a New Drug Application (NDA), as defined under 21 U.S.C. 355(b) et seq. for any Drug Product, or holds the rights to any such NDA. 

Phase II trials in breast cancer and head and neck cancer were underway in Japan by November 2005 and in brain cancer by December 2005. By July 2005, a phase III trial in solid tumors had started. In February 2006, the company listed the drug in phase III trials for NSCLC. AstraZeneca plans to file Vandetanib for marketing authorization apphcation (MAA) in Europe and new drug application (NDA) in the USA not earlier then 2007. 

In 1992, a New Drug Application for taxol was filed by BMS. The FDA approved taxol for the treatment of refractory ovarian cancer 6 months after filing. In December 1992, the FDA approved taxol for marketing. It had been 30 years since the first collection of Pacific yew for testing at the Research Triangle Institute. In 1993, taxol was marketed by BMS. In 1994, a supplemental FDA approval was issued for taxol in treatment of metastatic breast cancer. 

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