Alex Olinger
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.…
Read MoreChronic 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…
Read MoreThe curb-cut effect refers to the broad and often unexpected benefits of designing for accessibility. Originally intended to assist people with physical disabilities, curb cuts have since proven beneficial for many others—parents with strollers, delivery workers with carts, and even travelers with rolling luggage. This concept extends beyond physical infrastructure to digital tools, including technology-enabled…
Read MoreAs clinical trials evolve in the digital age, e-consent has emerged as a promising tool to enhance patient engagement, streamline processes, and improve regulatory compliance. While the benefits of e-consent are significant, implementing this technology also presents several challenges that sponsors and clinical teams must navigate. Below, we’ll explore both the benefits and challenges of…
Read MoreLean authoring, a method popularized by medical writing expert Gregory Cuppan, emphasizes streamlined, focused writing that delivers key messages without unnecessary detail. It promises efficiency, but the reality of implementing lean authoring within a cross-functional team often involves substantial negotiation. Lean authoring becomes not a black-or-white process but, rather, an exercise in grayscale methodology. This…
Read MoreDeadlines to meet, projects to juggle, and dynamic demands? Work can be stressful at times. It’s no wonder people feel anxious and overwhelmed. Well, that’s when you might want to spend some time on a yoga mat! Physical and mental health are strongly related, and their relationship is well described in literature, too. Frequent stress…
Read MoreIn today’s ever-evolving work environment, shaped by the aftermath of the COVID-19 pandemic, the once-standard 9-to-5 office routine is rapidly becoming obsolete. This shift is ushering in the era of remote work, with various professions embracing change seamlessly. Among them, medical writing stands out as particularly well suited to adapting to this new way of…
Read MoreEstablishing 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…
Read MoreFor a drug to get on the market in the United States, it must go through a rigorous review by FDA’s Center for Drug Evaluation and Research (CDER) (or, in some cases, the Center for Biologics Evaluation and Research [CBER]). Drugs are tested in preclinical and then in clinical settings to assess safety and efficacy.…
Read MoreManaging information requests from health authorities such as the FDA is a critical aspect of regulatory compliance for pharmaceutical companies. These interactions can directly affect the pace of your product’s approval process. To succeed, it’s important to follow best practices that focus on clarity, accuracy, and efficient project management. A key component to success is…
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