Dossier submission process of drug product in USA, Europe and India: Dossier submission for drug product - Image 1

£54.00

LAP Lambert Academic Publishing Dossier submission process of drug product in USA, Europe and India: Dossier submission for drug product

Name: Dossier submission process of drug product in USA, Europe and India: Dossier submission for drug product
Brand: LAP Lambert Academic Publishing
Price: 54.0 GBP
Availability: InStock

Philosophy

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Description

Dossier is a file document submitted based on the requirement of regulatory agency for the approval of drug product. It is essential to submit dossier file in the form of common technical document in USA and EUROPE. Generic drugs are approved under ANDA submission. An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.The ANDA contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.The European Medicines Agency (EMA) is a European agency for the evaluation of medicinal products.The EMA operates as a decentralized scientific agency of the European Union and is responsible for the protection and promotion of human and animal health, specifically through the coordination of evaluation and monitoring of centrally authorized products and national referrals, developing technical guidance and providing scientific advice.

Product Specifications

Brand: LAP Lambert Academic Publishing
Format: paperback
ASIN: 3659115665
Category: Books > Subjects > Politics, Philosophy & Social Sciences > Philosophy
Domain: Amazon UK
Release Date: 26 May 2012
Listed Since: 29 May 2012

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LAP Lambert Academic Publishing Dossier submission process of drug product in USA, Europe and India: Dossier submission for drug product

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