Combination products
Gopalaswamy, Smita.
Combination products regulatory challenges and successful product developement / [electronic resource] : Smita Gopalaswamy and Venky Gopalaswamy. - Boca Raton, Fla. : Taylor & Francis, 2008. - xvi, 241 p. : ill.
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.
Mode of access: World Wide Web.
9781420064513 (ebook : PDF)
United States. Food and Drug Administration.
Drugs--Standards--United States.
Medical instruments and apparatus--Standards--United States.
Biological products--Standards--United States.
Electronic books.
QV 26 / G659c 2008
Combination products regulatory challenges and successful product developement / [electronic resource] : Smita Gopalaswamy and Venky Gopalaswamy. - Boca Raton, Fla. : Taylor & Francis, 2008. - xvi, 241 p. : ill.
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.
Mode of access: World Wide Web.
9781420064513 (ebook : PDF)
United States. Food and Drug Administration.
Drugs--Standards--United States.
Medical instruments and apparatus--Standards--United States.
Biological products--Standards--United States.
Electronic books.
QV 26 / G659c 2008