Combination products
Subtitle: regulatory challenges and successful product developement
By: Smita Gopalaswamy, Venky Gopalaswamy.
Contributors: Gopalaswamy, Venky.
Publisher: CRC Press
Published: 2008
Place of publication: Boca Raton
Language: eng
Number of pages: 241
ISBN-13: 9781420064469
Subjects: United States. -- Food and Drug Administration; United States. -- Food and Drug Administration; Drugs -- Standards -- United States; Medical instruments and apparatus -- Standards -- United States; Biological products -- Standards -- United States; Equipment Design -- standards -- United States; Pharmaceutical Preparations -- standards -- United States; Biological Products -- standards -- United States; Device Approval -- standards -- United States; Equipment and Supplies -- standards -- United States
Notes: Includes bibliographical references and index.
Table of contents: title: Overview of combination products; title: Ensuring successful combination product development; title: Overview of FDA and other regulatory agency expectations; title: Resource requirements; title: Manufacturing of combination products; title: Challenges and pitfalls to avoid with combination products; title: Postlaunch compliance requirements; title: Agency audits and challenges.