FDA Inks $49.9 Million Deal with SAS
SAS will extend a 40-year partnership with the US Food and Drug Administration (FDA) to expand its capabilities in natural language processing, artificial intelligence, and machine learning capabilities through the SAS Viya platform. Through a five-year, $49.9 million Blanket Purchase Agreement, SAS will support digital transformation efforts underway in the FDA.
The initial projects will be with the FDA’s Center for Drug Evaluation and Research. Through the SAS partnership, the FDA will:
- Advance CDER’s initiative to modernize drug regulatory programs.
- Provide analytically driven drug manufacturing facility surveillance.
- Better fulfill the center’s mission through other key initiatives.
For more on this deal, click here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
