The latest episode of Denatured features a discussion on the U.S. Food and Drug Administration's shift from requiring two pivotal studies to just one for new drug applications, according to a Mar. 12 podcast episode. Jennifer C. Smith-Parker, director of insights at BioSpace, hosts the conversation with Oxana Iliach, senior director of regulatory strategy at Certara, and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions.
This change by the FDA is significant because it sets a higher standard for data collection and risk-based management in clinical trials. The move is expected to impact how sponsors approach trial design and regulatory submissions.
During the episode, Smith-Parker speaks with Iliach and Pomerantseva about what this new requirement means for companies seeking approval for new drugs. They discuss the challenges sponsors may face as they adapt to stricter expectations around data quality and oversight.
The guests also share their perspectives on how organizations can prepare for these changes by strengthening their approaches to risk-based quality management and ensuring robust data collection processes are in place.
A disclaimer notes that "the views expressed in this discussion by guests are their own and do not represent those of their organizations." Listeners can access the full conversation on Spotify, Apple Podcasts, Amazon Music, or iHeart.
