Title: COMPARATIVE STUDY ON NEW DRUG APPLICATION PROCEDURE IN US, EU & INDIA: NDA Process in Different Countries
Publisher: LAP LAMBERT Academic Publishing
Publication Date: 2022
Language: English
ISBN 10: 6204748289
ISBN 13: 9786204748283
Binding: Soft cover
Condition: New

About this title

Synopsis

Developing a new drug requires a great amount of research work in chemistry, manufacturing, preclinical science, and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness, and quality control of a new drug product to serve public health. Every country has its own regulatory authority, which is responsible to enforce the rules & regulations and issuing guidelines to regulate the marketing of the drugs. This book focuses on the New Drug Application (NDA) approval process in different countries like the USA, Europe, and India.

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