Combination products regulatory challenges and successful product developement
by
 
Gopalaswamy, Smita.

Title
: 
Combination products regulatory challenges and successful product developement

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.

Electronic Access
: 
Distributed by publisher. Purchase or institutional license may be required for access.


LibraryMaterial TypeItem BarcodeShelf Number[[missing key: search.ChildField.HOLDING]]Status
Online LibraryE-Book291398-1001ONLINEElektronik Kütüphane