Medical Writing & Pharma

Pediatric drug development is one of the most challenging areas of regulatory writing, where precision, guidance interpretation, and strategic planning are crucial to achieving regulatory success. Medical writers play a pivotal role in ensuring that regulatory submissions are clear, compliant, and robust enough to meet the unique needs of pediatric populations. In this blog, we’ll…

As we age, the complexity of our health often increases, leading to the management of multiple chronic conditions. This reality gives rise to a phenomenon known as polypharmacy, or the simultaneous use of multiple medications in a single patient. Polypharmacy is a significant concern, particularly among geriatric patients, where it is sometimes referred to more…

According to the National Diabetes Statistics Report,1 5.7% of all United States (US) adults with type 1 diabetes rely on insulin for managing their condition. Additionally, approximately 12.3% of US adults starting using insulin within a year of their diabetes diagnosis. Insulin stands as a cornerstone in the treatment regimen, offering hope and vitality to…

In the ever-evolving battle against infectious diseases, the rise of drug-resistant infections poses a significant challenge to global health. These resilient bugs have developed mechanisms to withstand conventional treatments, leaving scientists and healthcare professionals searching for innovative solutions. In this blog post, we will explore the world of bug busters—the creative strategies, and the minds…

In the realm of pharmaceutical innovation, the Investigational New Drug (IND) application is a pivotal gateway, marking the initiation of clinical trials and the potential journey toward a groundbreaking new medication. Let’s explore the significance and process of an IND and its role in bringing novel therapies from the lab bench to the patient’s bedside.…

Chronic Kidney Disease of Unknown Etiology (CKDu) has emerged as a pressing public health concern, particularly in regions with high agricultural activity and limited access to healthcare. Afflicting predominantly rural communities in low- and middle-income countries, CKDu poses a significant challenge due to its elusive causes, devastating health consequences, and socioeconomic impact. The phenomenon of…

Establishing early alignment with the FDA on the rolling submission approach is pivotal to your success. Before you initiate any submission activities, ensure you have secured the FDA’s agreement on both the timing and the scope of your rolling submission. This early communication ensures that there are no surprises later and allows both you and…

What is a Biosimilar? In the scientific realm, biosimilars, akin to their reference products, are biologic medications. Approval for biosimilars hinges on demonstrating no clinically significant differences in safety and efficacy compared to the reference products. Picture them as biological siblings, crafted from the same sources as live cells or microbes, ensuring the same safety…

When pursuing a Biologics License Application (BLA) or New Drug Application (NDA), meeting timelines is crucial. However, the path to approval is often fraught with potential delays. Understanding these risks—and knowing how to mitigate them—can make or break your timeline. Top 10 most common risks and expert tips on how to manage them effectively 1.…

When preparing regulatory submissions, especially in fields like oncology, it’s crucial to focus on the end goal—the drug’s label or Summary of Product Characteristics (SmPC). These documents aren’t just regulatory requirements; they serve as the foundation for how the drug will be positioned in the market. Writing with the label in mind means threading key…