The shifting regulatory landscape demands that sponsors move beyond initial clinical evidence to secure approval. Success now hinges on proactive planning across chemistry, manufacturing, and controls (CMC), alongside rigorous protocol design. Experts from Premier Research, including Seth DePuy and Paulla Dennis, will address these challenges during a live webinar on September 17, 2026. The session focuses on synchronizing clinical and regulatory activities to minimize development risks for therapies targeting serious medical needs. By aligning cross-functional teams early, companies can better navigate inspection readiness and the complexities of confirmatory trial requirements, ensuring their programs maintain momentum toward patient access.
Navigating the Rebound in FDA Accelerated Approvals
Accelerated approvals accounted for nearly one-quarter of novel drug authorizations in 2025, a significant jump from 14% the previous year. As the FDA tightens requirements for confirmatory trials and regulatory compliance, pharmaceutical sponsors face mounting pressure to refine their development strategies far earlier in the clinical process.
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