Category: Pharmaceutical
-
2025 USFDA Guidances
Related to US regulatory intelligence, the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released a new guidance agenda (posted below) detailing the new and revised guidance documents scheduled for release this year. Many of the new and revised guidelines slated for release are for generic drugs, and many also address…
-
CDISC SDTM Mapping
Introduction Timely, clear and actionable data insights allow important clinical decisions to be made in real time. And earlier insights mean life-changing or life-enhancing medicines can be brought to those in need faster. When it comes to clinical trials, data is everything. Data analytics answers questions like Is a drug working? Do side effects exist?…
-
Regulatory Intelligence
Regulatory intelligence (RI) is the process of collecting, analyzing, and interpreting information about regulatory requirements, changes, and trends affecting a specific industry or organization. The US Food and Drug Administration (FDA) is one of the health authorities whose data is analyzed as part of RI. RI is important for ensuring compliance and competitiveness. It helps organizations adapt to the…