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Last updated on April 24, 2014 at 21:24 EDT

Latest United States Food and Drug Administration Stories

2014-04-16 12:29:50

IRVINE, Calif., April 16, 2014 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced today details for its previously announced conference call and webcast to discuss the United States Food and Drug Administration (FDA) 510(k) clearance of the UltraShape(TM) System for selective non-invasive fat cell destruction for the purpose of body contouring. http://photos.prnewswire.com/prnvar/20120528/535447 The...

2014-04-14 12:34:57

IRVINE, California, April 14, 2014 /PRNewswire/ -- Positions Syneron with Disruptive Product Offering in Fast Growing Body Contouring and Fat Treatment Market Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced today that it has received the United States Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape...

2014-04-02 08:33:56

ATLANTA, April 2, 2014 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA). This approval allows CryoLife to begin its pivotal clinical trial to gain approval to commercialize PerClot in the U.S. The Company plans to begin enrollment in...

2014-03-31 16:26:42

BOSTON, March 31, 2014 /PRNewswire/ -- About six months ago, the United States Food and Drug Administration (FDA) released new rules which require most medical devices distributed in the United States to bear a Unique Device Identification, or a UDI. Debara Reese, Vice President, Quality and Compliance, for global life sciences compliance consulting firm, Maetrics, recently spoke at the BioMed Conference in Boston where she explained, "The most common pitfall I've seen regarding UDI...

2014-01-07 08:30:44

SAN DIEGO, Jan. 7, 2014 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), today announced that the United States Food and Drug Administration (FDA) considers the recent resubmission of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application to be a complete response to the FDA's prior January 31, 2011 action letter. For the resubmission, the FDA has assigned a Prescription Drug User Fee Act goal date of June 10, 2014. If approved, the Company...

2013-11-25 08:26:54

Company will Resubmit the Contrave NDA in the Next Few Weeks - Potential Approval by June 2014 SAN DIEGO, Nov. 25, 2013 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced successful results of the interim analysis of the Light Study. Based on these results, the Company will resubmit the Contrave® New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in the next few weeks with potential approval by June 2014. "The interim...

2013-11-01 20:22:32

MOUNT PROSPECT, Ill., Nov. 1, 2013 /PRNewswire-USNewswire/ -- The National Association of Boards of Pharmacy® (NABP®) today issued a report stressing the continuing global public health threat posed by unapproved drug products distributed via the Internet. As detailed in the Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: October 2013, most rogue online drug sellers reviewed by NABP in the last three months offer foreign drug products or...

2013-09-16 08:28:23

CARLSBAD, Calif. and SAN DIEGO, Sept. 16, 2013 /PRNewswire/ -- Quidel Corporation (NASDAQ: QDEL) and Life Technologies Corporation (NASDAQ: LIFE) announced today that the United States Food and Drug Administration (FDA) has granted 510(k) clearances to the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV + hMPV assay, both for use on the QuantStudio(TM) Dx Real-Time PCR Instrument by Life Technologies. The QuantStudio(TM) Dx is Life Technologies' flagship instrument...

2013-09-06 12:24:39

ANNAPOLIS, Md., Sept. 6, 2013 /PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP) announced today that new data from the Company's SparVax(®) next-generation anthrax vaccine program were presented in two separate oral presentations at the 2013 Bacillus - ACT international anthrax conference in Victoria, British Columbia, Canada. In a presentation entitled "Development of an Immunopotency Assay as a Release and Stability Test for a Recombinant Protective Antigen (rPA) Anthrax Vaccine," Dr....

2013-08-28 23:25:18

Revolutionary Sciences weighs in: today, the most common injuries associated with autoclave use are burns. The Saniclave autoclaves reduces the risk of burns with a thermally protective outer shell. (PRWEB) August 28, 2013 Steam sterilization (autoclaving) is the single most effective form of sterilization. Although the United States Food and Drug Administration and ANSI/AAMI have recently increased their safety requirements, users are still concerned about the safety hazards of using an...