FDA Did the Right Thing in Pulling Avastin for Breast Cancer
If you want the FDA to approve more innovative, new drugs based on promising but early clinical results, you have to give the FDA a way to revoke those approvals later on, should larger trials prove that those drugs aren t as safe or effective as they first seemed. This is why the FDA should be congratulated for the way it has handled the Avastin breast cancer saga, and why I hope we will see ...

FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals
The U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

Artificial Pancreas - FDA Provides Options For Designs And Studies
A draft guidance to help artificial pancreas researchers and makers as they create and submit their devices for FDA approval has been issued by the Agency. Artificial pancreases are currently being designed and created for the treatment of diabetes type 1. The draft guidance provides flexible recommendations for the design and testing of devices so that they can still meet regulatory ...