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 This draft guidance describes updated scientific considerations regarding a comparative clinical study with efficacy endpoints … Read more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
The FDA has launched its PreCheck program and a new ANDA Prioritization pilot, ostensibly to address supply chain vulnerability by promoting domestic pharmaceutical manufacturing. Driven by the narrative that the globalization of drug production compromises U.S. safety and security, these programs offer expedited reviews for new U.S. sites and generic drugs made entirely with domestic … Read more
Supplement labels may look scientific, but many are nothing more than marketing spin cloaked in pseudo-medical jargon. Terms like “supports heart health” or “boosts brain function” trick consumers into believing supplements prevent diseases—without a shred of clinical proof. Add in industry-invented buzzwords like “cosmeceuticals,” and you have a billion-dollar deception thriving on FDA loopholes. Walk … Read more
Over the last two decades, adaptive trial designs have transitioned from being an avant-garde concept to a regulatory norm. The main challenge with adaptive trial design has been global acceptance of such designs in regions outside the US. The newly released ICH Guidance document harmonizes across regions the principles originally proposed in the FDA Guidance … Read more
