Episode 4- Guidelines for a Successful Investigational New Drug Filing in the US

Join us for a special episode of our podcast, hosted by Janet Overvelde, Innovaderm’s Senior Director in Project Management, live from the 2024 AAD in San Diego, CA. Janet interviews Staci Ellis, the Vice President and Head of Regulatory Affairs at RegDev Inc., a seasoned leader with a wealth of experience in Regulatory Affairs. They explore the guidelines for a successful Investigational New Drug (IND) filing in the US, discussing early engagement, strategic planning, aligning dose data with FDA safety assessments, and the importance of compliant Chemistry, Manufacturing, and Controls (CMC). Do not miss this episode packed with expert advice and valuable insights.