Case Study

Proactive Strategies For Meeting NDA Timelines Despite Last Minute Supplemental Study Requests

Lab Worker Trial Design

With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug. They needed to document the effect of a low-fat diet on the study drug pharmacokinetics, drug-drug interactions, impact on QT interval, and liver and kidney metabolism.

Learn having a CRO that is experienced in the common FDA-required studies for NDA submission can make or break the submission timeline. Nimble responses and expert logistics setups can make all the difference.

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