Preparing A New Drug Application (NDA) With A CDISC Conversion

Regulatory submissions are the most critical milestones in clinical research programs. Quality submissions can accelerate time to market, maximize research investments and bring the benefit of new treatments to patients sooner.

In August 2018, when the time came for RedHill Biopharma (Nasdaq: RDHL) to prepare its New Drug Application (NDA) for Talicia® (omeprazole magnesium, amoxicillin and rifabutin), the specialty biopharmaceutical company turned to Bioforum’s team of experts to prepare key components of the regulatory submission. Approved by the FDA for the treatment of H. pylori in adults in November 2019, Talicia® is the only available rifabutin-based therapy that addresses the growing resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies.