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The U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

Faster FDA Drug Reviews Should Benefit Cardium Therapeutics and CytRx Corporation
NEW YORK, NY-- - It has been a banner year already for the biotechnology sector with new chemical and molecular entity approvals reaching a 20-year high. Additionally, FDA officials claim drug applications ...