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 […]
The latest FDA Warning Letter and Inspection Observation Trends
Blog FDA Warning Letter and Inspection Observation Trends With the Food and Drug Administration (FDA) stepping up its enforcement efforts, companies are facing increased scrutiny in the form of more warning letters and inspections. However, staying informed and compliant with FDA regulations doesn’t have to be a daunting task. In this blog, we provide a […]
CDISC SEND Controlled Terminology Best Practices
Blog Are “Not Done” and “NOT DONE” the same? Not in CDISC SEND controlled terminology. The correct use of controlled terminology is a critical part of submitting study data to the FDA. It can be challenging, though. A PDF of the current CDISC SEND controlled terminology has several pages. It includes thousands of terms and […]
Best Practices for Enabling FDA SEND Compliance
Blog What is FDA SEND Compliance? The Clinical Data Interchange Standards Consortium (CDISC) created the standard. FDA SEND supports the approval process. SEND stands for the Standard for Exchange of Non-clinical Data. It’s vital to follow FDA SEND compliance regulation guidelines to streamline the approval process. The Study Data Tabulation Model(SDTM)is a standard for organizing […]
