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March 15, 2010 (Vol. 30, No. 6)

Navigating Electronic Submission Pathways

Specialized Software and Document-Preparation Services Can Streamline Process

  • An IND application submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies related to the drug in question. Many of the required documents come from peer-reviewed scholarly literature. Obtaining, assembling, transmitting, and managing this volume of materials— ...

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