ADVENTRX Receives FDA Clearance Under a Special Protocol Assessment to Initiate CoFactor Phase III Clinical Trial (PR Newswire via Yahoo! Finance)
ADVENTRX Pharmaceuticals, Inc. announced today that it reached an agreement under a special protocol assessment with the US Food and Drug Administration on the design of the Company's CoFactor Phase III clinical trial protocol.

Cipla, Sun get tentative FDA approvals (NDTV Profit)
MUMBAI (Reuters) - Cipla Ltd. has received tentative approval from the U.S. Food and Drug Administration for generic AIDS drug nevirapine in the tablet form, according to an FDA statement.

Medical Device Manufacturers Surpass 15,000 Companies; FDA Issues New Program (Industry Week)
May 22, 2006 -- Growing from 6,000 companies in 1997, to 15,000 in 2006, medical device manufacturers are producing 100,000 products compared to 84,000 in 1997. With this new influx of products, the Center for Devices and Radiological Health (CDRH) has launched the Medical Device Postmarket Transformation Initiative, which will allow the FDA to identify, analyze and act on problems with medical