Combination products regulatory challenges and successful product developement

Title:

Author:

Gopalaswamy, Smita.

ISBN:

9781420064513

Publication Information:

Boca Raton, Fla. : Taylor & Francis, 2008.

Physical Description:

xvi, 241 p. : ill.

Contents:

Overview and definitions of combination products -- Ensuring successful development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Post launch compliance requirements -- Agency audits and challenges.

Corporate Subject:

United States. Food and Drug Administration.

Subject Term:

Drugs -- Standards -- United States.

Medical instruments and apparatus -- Standards -- United States.

Biological products -- Standards -- United States.

Added Author:

Gopalaswamy, Venky.

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