Smita Gopalaswamy, Venky Gopalaswamy

Combination Products (eBook, ePUB)

Regulatory Challenges and Successful Product Development

• Format: ePub

Produktbeschreibung

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area.
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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 264
• Erscheinungstermin: 22. April 2008
• Englisch
• ISBN-13: 9781040068960
• Artikelnr.: 70018843

Autorenporträt

Smita Gopalaswamy, Venky Gopalaswamy

Inhaltsangabe

Introduction. 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. Conclusions.