Combination Products

Regulatory Challenges and Successful Product Development

By: Smita Gopalaswamy, Venky Gopalaswamy

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eText | 22 April 2008 | Edition Number 1

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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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