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FDA Approvals - Applied Biosystems Receives FDA 510(k) Clearance for Real-time PCR Instrument


Applied Biosystems Receives FDA 510(k) Clearance for Real-time PCR Instrument for Use with New Flu Test from U.S. ... (Centre Daily Times)
Applied Biosystems Inc. (NYSE:ABI) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new 7500 Fast Dx Real-Time PCR Instrument for use with the new CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) from the U.S. Centers for Disease Control and Prevention. While both products received ...

FDA Funding Will Increase In Tough Budget Year (Medical News Today)
The Alliance for a Stronger FDA applauded Congressional actions to assure increased funding for FDA in fiscal year 2009. Under the Continuing Resolution (CR), FDA will be able to spend at a higher rate in FY 2009 than it did in the current fiscal year. The CR was passed by the House last Wednesday and by the Senate on Saturday.

Arana Files IND For Lead Anti-Inflammatory Product ART621 In Rheumatoid Arthritis (RA) Indication (Medical News Today)
Biotechnology company Arana Therapeutics Limited (ASX: AAH) announced it has submitted an Investigational New Drug application (IND) to the FDA (U.S. Food and Drug Administration) for the anti-inflammatory product ART621 in a rheumatoid arthritis (RA) indication.
 

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