Case Study

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

FDA advisory committees, biologicals, clinical trials, drug approval, NDA, pharmaceutical, regulation

The Case: 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.

The Facts: 

Sponsor: Midsize pharmaceutical company

Study Location: Worldwide’s Clinical Pharmacology Unit (CPU) in San Antonio, Texas, and partner sites in the United States.

The Sponsor's Challenges:

Timeline: The last-minute FDA requirements had the potential to significantly delay NDA submission for a program that was already near completion.

Logistics: With five unexpected studies to execute, operations had to align seamlessly to enable time-saving multitasking on clinical logistics and reporting requirements.

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