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Regulatory Challenges and Successful Product Development
By Smita Gopalaswamy, Venky Gopalaswamy
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...
Published April 21st 2008 by CRC Press
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