Prashant Kumar

The landscape of cellular and gene therapy (CGT) manufacturing has shifted from isolated lot-release testing toward quality risk management. With the issuance of the FDA’s final guidance, Potency Assurance for Cellular and Gene Therapy Products, regulators have updated the 2011 release-testing framework to emphasize a lifecycle strategy. For regulatory affairs and CMC professionals, this document … Read more

Navigating the evolving landscape of combination product oversight requires regulatory strategy to be as dynamic as the technology itself. With the release of the updated FDA draft guidance on Essential Drug Delivery Device Performance Characteristics (EDDCs), regulatory professionals are presented with a refined framework designed to harmonize drug delivery performance with the Quality Management System … Read more

The last decade, the FDA has been moving the medical device regulatory submissions to a standardized electronic template, the eSTAR. This electronic template replaces guesswork and streamlines regulatory submissions. With the latest expansion of the eSTAR template, now the Investigational Device Exemption (IDE) applications also can be created using the eSTAR template.  The latest FDA … Read more

The rapid evolution of genome editing technologies has brought us to the threshold of true precision medicine. For patients suffering from monogenic diseases caused by diverse, patient-specific gene variants, standard gene therapies often fall short. Recognizing this gap, the FDA released a new guidance to suggest how sponsors can bundle multiple product variants under a … Read more

Digital health technologies are rapidly transforming prescription therapies from traditional chemical compounds into integrated software-and-drug health systems. As mobile applications and connected devices increasingly accompany pharmaceuticals, life science companies face a complex regulatory matrix. To clarify these boundaries, the FDA issued a new guidance outlining how drug labeling authorities apply to Prescription Drug Use-Related Software … Read more

Embedded pragmatic clinical trials (ePCTs) test interventions in routine healthcare settings using existing infrastructure, such as electronic health records (EHRs) and frontline clinicians. Unlike traditional trials with strict eligibility criteria and controlled conditions, ePCTs enroll broader, more representative populations to assess whether interventions work in everyday clinical practice. The FDA supports this approach through initiatives … Read more

Navigating medical device biocompatibility evaluations can often feel like solving a maze blindfolded, especially when trying to reconcile shifting global standards with FDA expectations. Fortunately, the FDA recently hosted the final installment of its comprehensive three-part town hall series, bringing together regulatory experts to demystify toxicological risk assessments (TRAs). Drawing from updated consensus standards like … Read more

For decades, bringing a rare disease therapy through the regulatory gauntlet has felt less like a science and more like navigating an obstacle course blindfolded. With roughly ninety-five percent of recognized rare conditions still lacking an approved treatment, the human and economic tolls have continued to mount unabated. Traditional clinical trial paradigms simply break down … Read more

The mandatory implementation of FDA’s electronic Individual Case Safety Report (ICSR) standards was announced this week requiring an overhaul of legacy safety reporting processes. With this announcement, FDA formally adopted ICH E2B(R3) framework for compliance. Sponsors must immediately align data architectures to satisfy stringent validation parameters and avoid costly workflow rejections.   The goal of ICH … Read more

For years, the scientific community has debated and critiqued a purported “replication crisis” that threatens to undermine public trust in medical research. Headlines frequently blare that dozens of published preclinical and clinical studies cannot be successfully reproduced under identical laboratory conditions. Yet treating reproducibility as a simple, binary pass-or-fail test fundamentally misrepresents the diverse, complex … Read more