Prashant Kumar A major shift is unfolding in the world of CAR-T-cell therapy, and it didn’t come through a formal FDA guidance or regulation. Instead, it arrived as a “perspective” article in a top medical journal, authored by the FDA’s CBER leadership. Beneath its calm academic tone lies a seismic message: the era of open-label CAR T … Read more
The FDA has issued an updated version of its eCopy Program guidance, providing clarifications to an established electronic submission framework in place for more than a decade. The revisions primarily refine expectations, align terminology, and integrate the program more closely with eSTAR and current electronic submission pathways. For medical device sponsors, the document functions as … Read more
Animal testing has long been considered a necessary step in drug development; however, the FDA is now revising that narrative. A new draft guidance aims to modernize outdated toxicology practices and significantly reduce the use of animals in the development of monoclonal antibodies. This shift not only reflects scientific progress but also a broader commitment … Read more
FDAMap, a global regulatory and clinical expert firm, is significantly expanding its focus on regenerative medicine in South America. The company is actively collaborating with local healthcare providers and patients to advance access to and the development of safe, non-manipulated stem cell therapies in the region. FDAMap’s core initiative centers on non-manipulated stem cells, primarily … Read more
The Gulf Cooperation Council (GCC) region is actively focusing on developing its healthcare sector, particularly in regenerative medicine using established stem cell approaches. FDAMap, led by the world’s leading authority on regenerative medicine, Dr. Mukesh Kumar, initiated development of stem cell therapies in the region. Regenerative therapies using non-manipulated stem cells, such as Mesenchymal Stem … Read more
For years, randomized clinical trials (RCTs) have been the gold standard for drug approvals, but they often fall short of reflecting real-world clinical practice. Real-World Evidence (RWE), data generated during routine clinical use, is expected to address this deficiency. While the US Food and Drug Administration (FDA) has been actively incorporating RWE, a recent study … Read more
Artificial Intelligence (AI) offers unprecedented tools for diagnosis and treatment. However, a new cross-sectional study of nearly 1,000 FDA-approved AI-enabled medical devices reveals a troubling gap between regulatory approval and robust clinical evidence. Questions are raised about the reliability of these tools to perform safely and effectively for every patient, regardless of their background or … Read more
Imagine dedicating years and millions of dollars to developing a life-changing new medicine, only to have its application refused by the FDA due to a preventable administrative error. This costly setback, the Refuse to File (RTF) action, consumes immense resources and delays promising treatments from reaching patients. The FDA RTF checklists used by its own … Read more
The federal government is in a funding lapse, a formal way of saying Congress didn’t pass a budget, and the government has “shut down.” If you’re a company developing a new medicine or device, you might assume the FDA’s doors are completely closed—but that is a critical misconception. While a shutdown does create significant regulatory … Read more
A key question for the developers of biosimilars is the studies needed to support interchangeability with the reference biologic. A new FDA Guidance Document, released this week, provides the current rationale for the need for a Comparative Efficacy Study (CES). This draft guidance describes updated scientific considerations regarding a comparative clinical study with efficacy endpoints … Read more
