Navigating US FDA IND Submissions: Non-clinical Requirements and Compliance for Research and Testing Facilities and Communications with US FDA

Topics Covered:

This focused virtual symposium provided critical insights into the US FDA Investigational New Drug (IND) application process with an emphasis on non-clinical data, nonclinical writing and compliance requirements. The session targeted Thai testing facilities, regulatory agencies, pharmaceutical, and biotech researchers keen to understand US FDA regulatory expectations and best practices to facilitate successful IND submissions along with communication channels with US FDA during clinical development stage of the product and effective meeting management principles with USFDA

• Step-by-step overview of the IND submission process (21 CFR Part 312)
• Detailed guidance on nonclinical data and document preparation within the electronic Common Technical Document (eCTD) framework
• Strategies for effective communication and engagement with the FDA, including pre-IND meeting preparations
• Insights on key IND milestones and regulatory expectations from US FDA reviewers