We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Government Accountability Office (GAO) laid out policy options for dealing with the challenges of machine learning in drug development in a report released yesterday — noting that uncertainty about potential regulation of machine learning is hindering its adoption. Read More
A congressional committee may be planning to throw its weight behind “complex generics” as part of a push to increase generic options and lower drug costs. Read More
Post-inspection Official Action Indicated (OAI) classifications by CDER and CBER have dropped sharply in recent years, according to the latest data from the FDA’s Inspection Classification Database. Read More
FDA investigators found API production records all over the floor, desks and cabinets of the quality unit in Yibin Lihao Bio-technical’s Sichuan, China facility. Read More
