iwewlkws Investing in quality management isn’t just about regulatory compliance; it’s a strategic move that boosts efficiency, profitability, and public health outcomes. An FDA white paper presents a systematic analysis of how mature quality systems can provide both economic and public health benefits to the industry. There are no surprises in the paper; it provides the … Read more
Observational studies play an important role in medicine by providing insights not available from controlled clinical trials, but many suffer from poor transparency and inconsistent methods. Their potential is often compromised by bias, data dredging, and unverifiable conclusions. Could registering the observational studies address the concerns with their reliability and unlock their full potential to … Read more
Artificial intelligence is increasingly powering your doctor’s decisions. But as AI advice becomes a staple in modern healthcare, a surprising trend is emerging: patients aren’t quite ready to trust it. Artificial intelligence (AI) is making its mark on healthcare, offering unprecedented support in diagnostics, treatment planning, and even behind-the-scenes administrative work. But new research reveals … Read more
Real-world data is being hailed as the next big thing in clinical research, but the reality is a bit messier. Until we clean up the data and rethink how we collect it, real-world evidence risks being a shiny promise with little power. The explosion of electronic health records (EHRs) and digital claims databases was supposed … Read more
Two-to-one (2:1) randomization has become a common feature in clinical trial design, particularly in oncology, often under the belief that it helps recruit more patients by increasing the chances of receiving the experimental treatment. But according to Freidlin and Korn in their recent JCO Oncology Practice article, this practice may be more problematic than promising. … Read more
In a sweeping regulatory shift that’s already sending shockwaves through the global supply chain, the U.S. Food and Drug Administration (FDA) has officially revoked the longstanding exemption for low-value imports. As of July 9, every shipment of FDA-regulated products—regardless of its dollar value or size—must now undergo full FDA review. This marks the end of … Read more
As the landscape of clinical research becomes increasingly complex and patient-centric, Contract Research Organizations (CROs) are under pressure to deliver faster, more efficient, and high-quality results. While CROs bring operational excellence to the table, integrating Independent Physician Services can unlock a new level of clinical and regulatory value for sponsors. At FDAMap, we recognize the … Read more
Choosing the right Contract Research Organization (CRO) is one of the most critical decisions a sponsor will make during a drug or device development program. The right CRO can accelerate timelines, improve data quality, and ensure regulatory compliance. The wrong one can derail your project. At FDAMap, we help sponsors make informed outsourcing decisions. Here … Read more
When it comes to conducting clinical trials and managing regulatory affairs, many life sciences companies consider partnering with a Contract Research Organization (CRO). CROs offer specialized expertise, infrastructure, and resources that can help streamline complex drug development processes. However, this collaboration also comes with certain trade-offs. At FDAMap, we believe it’s essential for sponsors to … Read more
Antibacterial therapies targeting serious infections in patients with limited or no therapeutic options are hard to develop for scientific, logistical, and financial reasons. FDA’s latest guidance describes the FDA’s expectations for developers of antibiotics for patients with an unmet medical need for a serious bacterial infection. The guidance articulates a science- and risk-based framework for … Read more
