News|Articles|March 23, 2026

Four FDA Actions Reshaping Drug Development in 2026

In the first months of 2026, the FDA has moved on multiple fronts to modernize how drugs are developed, evaluated, and approved, signaling a broader regulatory shift toward flexibility, mechanism-based evidence, and human-centric science.

Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency is recalibrating its evidentiary standards to align with advances in biology, trial methodology, and technology. Taken together, these actions have meaningful implications for how sponsors design studies, plan nonclinical programs, and engage with regulators across the development lifecycle.

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Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection

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Mixed Outsourcing Models Are Spreading. Is Sponsor Oversight Keeping Up?

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Building Trust Into Oncology Real-World Evidence: Q&A with Saamir Pasha and Carole Berini, Ontada

In this Q&A, Saamir Pasha and Carole Berini, PhD, of Ontada discuss what it takes to harmonize fragmented oncology data into reliable real-world evidence, how lab markers can proxy for missing functional status data, and where the biggest remaining barriers to consistent RWE generation lie.

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What a Practical Roadmap for FDA and EMA Quality Frameworks Actually Looks Like

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, describe what operationalizing regulatory-grade quality frameworks requires—and why fit-for-purpose evidence generation is a transparency and documentation discipline, not just a data cleanliness exercise.

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October 8th, 2026

Real-Time Data, Right-Time Decisions: Rethinking Analysis Frequency in RBQM

Real-time RBQM requires proportionate analysis frequency matched to data arrival and issue criticality, not continuous reanalysis, because signal churn from over-frequent runs creates alert fatigue and operational noise that obscures meaningful deterioration.

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October 15th, 2026

Endpoints That Reflect What Patients Actually Value: Who Decides What Counts as Trial Success

Clinical trial endpoints define what success looks like, but patients and caregivers are rarely the ones setting that definition, and the gap between what trials measure and what patients actually value is showing up in post-approval evidence, regulatory submissions, and the design rooms where protocols are written.

October 14th, 2026

FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations

A new white paper and public engagement process outline the FDA’s commitment to building fit-for-purpose evidentiary standards, stronger patient voice integration, and greater regulatory predictability across rare disease drug development and review.

October 6th, 2026

Beyond the Molecule: Why Radiopharmaceutical Trials Require a New Operating Model

Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only as fast as the infrastructure, data, and cross-functional decisions required to deliver it.