FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submission

A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway

For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory success. The Pre-IND meeting—while technically optional—is a powerful opportunity to align with FDA on your development strategy, clarify expectations, and proactively identify potential pitfalls.

In this whitepaper, ProPharma’s regulatory experts unpack what it takes to prepare for and execute a successful Pre-IND meeting tailored to the unique nuances of 505(b)(2) submissions. From effective question formulation and bridging strategies to avoiding common pitfalls, this guide provides actionable insights for setting your program on the right regulatory course.

What You’ll Learn:

• The strategic role of Pre-IND meetings in 505(b)(2) NDA development

• How to effectively structure and submit a Pre-IND meeting request to FDA

• Key elements of a strong briefing package and question strategy

• Best practices for cross-functional meeting preparation and follow-up

• Common mistakes to avoid—and how to ensure your questions elicit meaningful FDA feedback

Whether you’re developing a reformulated product, new dosage form, or combination product, a well-planned Pre-IND meeting can be the difference between costly delays and a clear path to approval.

👉 Download the whitepaper to learn how to get the most out of your Pre-IND meeting.