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Demystifying the US IND process for initiation of clinical trials
Published on: Feb 20th, 2024
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. In this webinar, we covered the steps and key components required for comprehensive and compelling submission, as well as strategies for effective communication with the FDA during the review process.
We examined how to streamline the IND process by guiding you on making the right decisions at each stage, clarifying the sponsor’s reporting obligations after an IND submission, and the FDA’s actions that may occur during the lifespan of the IND.
Some learning objectives:
- What are the critical elements for a successful IND?
- How to get the most from FDA pre-IND meetings?
- How to avoid a clinical hold?
SAMPLE OF THE WEBINAR
Demystifying the US IND Process for Initiation of Clinical Trials (Teaser)
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