Synterex Blog

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.

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.

According to the National Diabetes Statistics Report, 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 started using insulin within a year of their diabetes diagnosis.

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 the ever-evolving landscape of medical research, drug repurposing has emerged as a groundbreaking approach, proving that sometimes old dogs can indeed learn new tricks.  Drug repurposing, also known as drug repositioning or drug reprofiling, refers to the process of identifying new uses for existing drugs that are already approved for other indications.

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.

For a drug to get on the market in the United States, it must go through a rigorous review by the FDA's Center for Drug Evaluation and Research (CDER) (or, in some cases, the Center for Biologics Evaluation and Research [CBER]).