Prashant Kumar

The FDA’s Digital Health Center of Excellence recently operationalized the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot Program to address the dichotomy between stringent premarket review timelines and iterative software life cycles. Launched in tandem with the Center for Medicare and Medicaid Innovation’s (CMMI) ACCESS model, TEMPO establishes an unprecedented mechanism for early-stage real-world deployment. Understanding the mechanics of this pilot … Read more

For decades, pregnant women have remained one of the most systematically excluded populations in pre-approval clinical development programs. As a result, many therapeutics enter the market with limited or no human pregnancy safety data despite anticipated real-world exposure shortly after commercialization. FDA’s May 2026 guidance, Postapproval Pregnancy Safety Studies, represents a significant evolution in regulatory expectations for pregnancy pharmacovigilance and real-world evidence generation. … Read more

The integration of generative AI into clinical workflows has triggered a “shadow IT” movement, where practitioners leverage unvetted Large Language Models (LLMs) to manage increasing administrative burdens without official institutional oversight. While platforms like OpenEvidence offer high-velocity access to peer-reviewed literature, the lack of transparency in these non-deterministic systems creates a significant “black box” liability. Regulatory professionals … Read more

The U.S. Food and Drug Administration recently unveiled a provocative shift in its oversight strategy by launching one-day inspectional assessments for manufacturing facilities. This program moves away from the multi-day, comprehensive deep dives that have long been the gold standard of regulatory compliance. By focusing on high-priority, risk-based indicators, the agency aims to broaden its … Read more

The Food and Drug Administration is no longer just a regulator of medicine; it is becoming a powerhouse of data science. For decades, the agency struggled under the weight of massive application backlogs and fragmented legacy systems. Today, the FDA is undergoing a digital metamorphosis, integrating sophisticated AI tools like “Elsa” to streamline how we ensure public … Read more

In the complex landscape of pediatric nutrition, the stability of the infant formula market remains a paramount concern for both federal regulators and industry stakeholders. Recent years have demonstrated that even minor supply chain disruptions can lead to significant public health crises and socioeconomic volatility. To fortify consumer confidence and ensure product integrity, the FDA has prioritized rigorous oversight through … Read more

The traditional drug development lifecycle has long been characterized by a punctuated equilibrium—long periods of intense activity followed by a “regulatory hiatus” where data sits idle during submission prep. For pharmaceutical executives and regulatory leads, this delay represents not just a cost center, but a barrier to patient access for life-saving therapies. The FDA is now actively dismantling … Read more

The landscape of genomic medicine is shifting rapidly, necessitating a regulatory framework that is as dynamic as the technologies it oversees. In 2024, FDA released a guidance document discussing strategic considerations for developing cell and gene therapy products. A new guidance release last month serves as a specialized technical extension of the foundational January 2024 GE Guidance, focusing squarely on the analytical rigor required for NGS-based assessments. … Read more

When the clock is ticking for a patient who has exhausted every approved therapeutic intervention, the distinction between a “clinical trial” and “clinical survival” becomes life-defining. For the critically ill, the dual pillars of Expanded Access (EA) and Right to Try (RTT) represent more than just regulatory pathways; they are the final conduits of hope … Read more

Building on our previous discussion of the “Single-Trial Pivot,” we’ve seen the FDA move away from the rigid 1962 dual-study precedent toward a more flexible, evidence-based approach for precision therapies. But while that shift was initially signaled through journal articles and informal policy trends, the Agency has now codified a critical component of this evolution. With the release of the new … Read more