TY  - BOOK
AU  - Gopalaswamy,Smita
AU  - Gopalaswamy,Venky
TI  - Combination products: regulatory challenges and successful product developement 
SN  - 9781420064469 (hardcover : alk. paper)
PY  - 2008///
CY  - Boca Raton
PB  - CRC Press
KW  - United States
KW  - Food and Drug Administration
KW  - Drugs
KW  - Standards
KW  - Medical instruments and apparatus
KW  - Biological products
KW  - Equipment Design
KW  - standards
KW  - Pharmaceutical Preparations
KW  - Biological Products
KW  - Device Approval
KW  - Equipment and Supplies
N1  - 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
UR  - http://www.loc.gov/catdir/toc/ecip082/2007043090.html
ER  -