Normal view MARC view ISBD view

Gopalaswamy, Smita

Combination products : regulatory challenges and successful product developement / Smita Gopalaswamy, Venky Gopalaswamy - Boca Raton : CRC Press, c2008 - xvi, 241 p. : ill. ; 25 cm.

Includes bibliographical references and index

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

ISBN: 9781420064469 (hardcover : alk. paper) 1420064460 (hardcover : alk. paper)

Subjects--Corporate Names:
United States Food and Drug Administration
United States Food and Drug Administration

Subjects--Topical Terms:
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