Day: October 23, 2025

For the last decade, the FDA emphasized that what matters most in modern drug development is the patient’s voice. The latest guidance on Patient-Focused Drug Development (PFDD) charts a detailed roadmap for integrating patient experience data into the heart of clinical trials. For drug and biologic sponsors, this isn’t just a regulatory update—it’s a strategic … Read more

For patients facing terminal or debilitating illnesses, time is not on their side. The FDA’s Expanded Access (Compassionate Use) program and the more recent Right to Try (RTT) pathway both offer hope when no approved therapies remain. As the FDA’s 2025 guidance reaffirms, decades of experience with compassionate use and the emergence of RTT have … Read more