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FDA Approvals - FDA Accepts Zingo(TM) Supplemental New Drug Application To Reduce Pain


FDA Accepts Zingo(TM) Supplemental New Drug Application To Reduce Pain Associated With Peripheral Needle Insertion ... (Medical News Today)
Anesiva, Inc. (Nasdaq: ANSV) announced that the U.S. Food and Drug Administration (FDA) has accepted the company's electronic supplemental New Drug Application (sNDA) filing to expand the indication for Zingo to treat pain associated with peripheral IV insertions and blood draws in adults.

Covidien Receives FDA Clearance To Market Single-Incision Laparoscopic Surgery (SILS(TM)) Kit (Medical News Today)
Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, announced that its Surgical Devices business unit has received FDA 510(k) clearance to market the Covidien SILS Procedure Kit, indicated for Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.

FDA Will Monitor Medical Records Of Medicare Beneficiaries To Identify Potential Prescription Drug, Medical Device ... (Medical News Today)
HHS on Thursday announced the creation of a new program that will allow FDA, state agencies and academic researchers to use medical record data to ensure drugs and medical devices are safe for consumers after they enter the market, the Washington Post reports (Stein, Washington Post, 5/23). The so-called "Sentinel Initiative" has been discussed for years, according to the New York Times.
 

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