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The Top Challenges Facing Today’s SEND Submission

Blog The Biggest SEND Submission Challenges for 2023 In today’s data-driven world, industries across the board are embracing data standardization to ensure uniformity and maintain organization. This is particularly important for the United States Food and Drug Administration (FDA), as they regulate a wide range of products that people consume or use, such as medications, […]

Understanding SENDIG v3.1.1: A Comprehensive Guide

Blog Do You Wish You Knew More About SENDIG v3.1.1? Struggling to grasp the complexities of the Standard for Exchange of Nonclinical Data? Navigating this essential aspect of your business can be challenging. If you’re not well-versed in understanding SENDIG v3.1.1, errors could lead to costly consequences for your organization. Our all-encompassing guide simplifies SENDIG […]

Submitting NDAs: A Key Milestone in the Drug Development Journey

Blog Submitting NDAs: A Pivotal Milestone in the Drug Development Journey Developing a new drug can be lengthy and complex, often taking 12-15 years before receiving approval in the United States. A crucial component in this journey is submitting NDAs (New Drug Applications), which is both complex and challenging. The process demands considerable investment, expertise, […]

Overcoming Challenges in Complying with SENDIG v3.1.1

Blog SENDIG v3.1.1 and the FDA Approval Process The cost of developing a new drug can be as high as $2.9 billion. Even after such a major investment of time and money, only a small percentage of drugs receive FDA approval. Making it through the Food and Drug Administration application process is difficult. The first […]

What Is FDAs DART Fit for Use Pilot All About?

Blog Expansion of FDA Data Standardization Rules with FDAs DART Fit For Use Pilot In drug development, the Food and Drug Administration (FDA) issued final guidance on reproductive and developmental toxicity. DART studies are critical for many potential new drugs. Standardizing this study data is a priority for the FDA. Standardization helps the agency process […]