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Most Popular Chapters *

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Orphan Drugs: Understanding the FDA Approval Process
Gauri Srivastava and Ashley Winslow

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Intellectual Property Protection for Biologics
Megan Brewster and Pallab Singh

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Preclinical Animal Models
Sunghee E. Park and Thomas P. Schaer

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FDA Drug Regulation: Investigational New Drug Applications
Bike Su Oner, Sergio R. Labra, and Shelly Fehr

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FDA Device Regulation: 510(k), PMA
Jason Van Batavia and Seth Goldenberg

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SBIR/STTR Grants: Application Guidance
Elliot Stein, David Lee, and Nalaka Gooneratne

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Innate Biases
Elana Meer

* Based on the average number of full-text downloads per day since the paper was posted.
» Updated as of 09/22/20.