BIO Office Hours: Crafting FDA Meeting Package (Day 1)

Successful interactions with the FDA are critical for regulatory development programs. Similarly, an investigational new drug (IND) submission is one of the key milestones in product development and one that sponsors want to get right the first time.

Regulatory experts with PSC Biotech will hold twenty-minute virtual appointments focused on tips for crafting meeting packages, including INTERACT packages and writing an IND submission.

What to expect in the overview & 20-minute Zoom session:

• Tips to increase the likelihood of FDA meeting acceptances
• Review of draft FDA/INTERACT meeting packages
• Tips for writing an IND submission