FDA Approvals - Abbott Receives FDA CLIA Waiver For Use Of Five Additional
Abbott Receives FDA CLIA Waiver For Use Of Five Additional Cartridges On The I-STAT Handheld Blood Analyzer (Medical News Today)
Abbott (NYSE: ABT) announced that the U.S. Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for five additional test cartridges used by its i-STAT handheld blood analyzer. Cartridges for E3+, EC4+ and 6+ aid the clinician in assessing a patient's metabolic state within a few minutes.
FDA Stem Cell Approval Breakthrough Laudable (Medical News Today)
Today the FDA announced approval for the first clinical trials on humans using Embryonic Stem Cells but Adult Stem Cell scientist Christian Drapeau says the experts may not be telling the whole story; Adult Stem Cells have greater potential with less risk. "While the FDA approval is an exciting step forward toward freeing science from the shackles of politics," said Drapeau.
IMPAX Receives Final FDA Approval for Omeprazole 40 mg Capsules (Business Wire via Yahoo! Finance)
HAYWARD, Calif.----IMPAX Laboratories, Inc. , through its generic drug division Global Pharmaceuticals, announced that yesterday the U.S. Food and Drug Administration granted final approval of the Company's Abbreviated New Drug Application for a generic version of Prilosec 40 mg Delayed-release Capsules.