Combination products [electronic resource] :regulatory challenges and successful product developement / Smita Gopalaswamy and Venky Gopalaswamy.
By: Gopalaswamy, Smita.
Contributor(s): Gopalaswamy, Venky.Material type: Computer filePublisher: Boca Raton, Fla. : Taylor & Francis, 2008Description: xvi, 241 p. : ill.ISBN: 9781420064513 (e-book : PDF); 9781420064469.Call number: 615.1 G659 Subject(s): United States. Food and Drug Administration | Drugs -- Standards -- United States | Medical instruments and apparatus -- Standards -- United States | Biological products -- Standards -- United StatesGenre/Form: Electronic books.Online resources: Distributed by publisher. Purchase or institutional license may be required for access.
Includes bibliographical references and index.
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.