Combination products [electronic resource] : regulatory challenges and successful product developement / Smita Gopalaswamy and Venky Gopalaswamy.
By: Gopalaswamy, Smita.
Contributor(s): Gopalaswamy, Venky.Material type: BookPublisher: Boca Raton, Fla. : Taylor & Francis, 2008Description: xvi, 241 p. : ill.ISBN: 9781420064513 (ebook : PDF).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.Additional physical formats: No titleOnline resources: Distributed by publisher. Purchase or institutional license may be required for access. Also available in print edition. CRC Press (http://www.crcpress.com)
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.
Also available in print edition. CRC Press (http://www.crcpress.com)
Mode of access: World Wide Web.