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Operationalizing Adaptive Design for FDA's One-Trial Era
Operationalizing Adaptive Design for FDA's One-Trial Era
October 20, 2026 : 11:00 AM ET
On February 18, 2026, the FDA...
1 min read
There is much for companies to consider before submitting an investigational new drug (IND) application to FDA. Planning, collecting the appropriate data, and effectively communicating with regulatory bodies can all help companies overcome challenges in the pre-clinical stage of development and efficiently prepare for IND applications.
There is no single solution to a successful regulatory strategy and IND application. Companies that want to excel in the IND application process must have an integrated and expertly coordinated approach to IND planning and execution. With proper project and risk management as well as rapid decision-making, your company can prepare a quality and timely IND application.
Three of Veristat's Regulatory experts - Mara Holinger, Kevin Hennegan, and Erin Flynn - weigh in and share their thoughts on common IND misconceptions.
Read the full article to learn more about the following:
- Important factors when planning for an IND
- Non-clinical and clinical pitfalls and misconceptions of IND applications
- Best practices for excelling in the IND application process
- And the future of IND applications
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