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 This draft guidance describes updated scientific considerations regarding a comparative clinical study with efficacy endpoints … Read more
Is AI a threat to the medical writers of the World? With the hype around AI bots doing things humans once did, the question is an obvious one, echoing across every knowledge industry and sparking anxiety. Sophisticated algorithms can already generate succinct text and perform lightning-fast data processing, but can they replace the fundamental skill … Read more
For the last decade, the FDA emphasized that what matters most in modern drug development is the patient’s voice. The latest guidance on Patient-Focused Drug Development (PFDD) charts a detailed roadmap for integrating patient experience data into the heart of clinical trials. For drug and biologic sponsors, this isn’t just a regulatory update—it’s a strategic … Read more
For patients facing terminal or debilitating illnesses, time is not on their side. The FDA’s Expanded Access (Compassionate Use) program and the more recent Right to Try (RTT) pathway both offer hope when no approved therapies remain. As the FDA’s 2025 guidance reaffirms, decades of experience with compassionate use and the emergence of RTT have … Read more
The landscape for vaccines in the United States has undergone a fundamental change. Federal signals once aligned around promoting innovation and rapid deployment; now, they increasingly emphasize restraint, cost containment, and skepticism toward newer technologies. Vaccine developers who view this shift not as an existential threat but as a call to adapt will be best … Read more
For more than a century, drug development has relied on animal studies as a gatekeeper for safety and toxicity. But in 2025, does that scientific justification still hold water? The original rationale — that animals are a safe proxy for humans — is deeply flawed, and institutional inertia (especially regulatory mandates) is the main reason … Read more
The FDA relies on Good Clinical Practice (GCP) inspections to evaluate regulatory compliance and verify data integrity, but unlike the US-based clinical sites, foreign GCP inspections are rare. A recent retrospective analysis provides a comprehensive look at the FDA’s GCP inspections conducted between fiscal years (FY) 2016 and 2018, shedding light on the agency’s operational … Read more
