Katrina’s Blog™

CDER researchers are working on approaches to predict drug effects on human systems before clinical trials start. My earlier post on Physiological Based Pharmacokinetic Modeling discusses one such approach used for predicting human systemic exposure following dose...

The Breakthrough Devices ProgramDevices and device-led combination may be eligible for enhanced access to reviewers and priority review through the Breakthrough Devices program if they meet the program criteria:The device provides for more effective treatment or...

Clinical Studies for Significant and Nonsignificant Risk Medical DevicesAn IDE is required for all medical devices that are considered significant risk devices. Guidance is available for sponsors and IRBs on what constitutes a significant risk device. Under the...

Investigational Device ExemptionMost PMAs and a small percentage of 510(k)s require clinical data to support the application. Good Clinical Practice (GCP) regulations apply to any clinical study of a device, whether that devices poses a significant risk (SR) or not...

If you share my interests, you have been following the news about the Amazon/Berkshire Hathaway/JP Morgan & Chase (often referred to as ABC) collaboration to find ways to change the experience of health care for patients, providers, and companies. The company has...