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?
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Sample of the webinar
Featured Speakers
Mark Gauthier
Senior Director, Regulatory Science, Drugs & Biologics
As Senior Director, Regulatory Science, Mark is responsible for assisting clients to define the regulatory strategies for the global development and…
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Sandra Cottrell
Head, Regulatory and Client Strategy
Sandra has 40+ years of experience and an in-depth knowledge of small-molecule and biological product development with a specialty in Regulatory Science across products' life cycle (pre-IND to post approval). Previously as head of Regulatory Affairs at multiple companies, she has extensive experience leading FDA and global health authority meetings as well as serving as an adjunct university professor for 19 years. She now prepares submission documentation and represents multiple clients to FDA as US or Regulatory Agent, preparing their teams for FDA meetings and participating in FDA negotiations.
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