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Vaccines and Related Biological Products Advisory Committee (November 20)
submitted by healthnews 48 days ago (via fda.gov)
This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. The Committee will meet in open session to hear updates of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Ce
 
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Antiviral Drugs Advisory Committee (December 2)
submitted by healthnews 48 days ago (via fda.gov)
The committee will begin with a closed session from 8 a.m. to 10:30 a.m., to permit discussion and review of trade secret and/or confidential information. Following the closed session, from 10:30 a.m. to 5 p.m., the meeting will be open to the public. The committee will discuss the safety and efficacy of new drug application (NDA) 20-725, Creon (pancrelipase delayed-release capsules), Solvay Pha
 
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Immunology Devices Panel (December 3)
submitted by healthnews 48 days ago (via fda.gov)
The committee will discuss and make recommendations on the premarket notification application for the Fujirebio HE4 EIA kit and associated Risk of Malignancy algorithm (ROMATM) Test. The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The HE4 EIA, used in conjunction with the ARCHITECT CA 125 II assay, creates a predictive probability of epithelial
 
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Anesthesiology and Respiratory Therapy Devices Panel (December 5)
submitted by healthnews 48 days ago (via fda.gov)
The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by Emphasys Medical Inc., for the Emphasys Zephyr Endobronchial Valve System, which is intended to improve Forced Expiratory Volume in the first second (FEV1) and 6- minute walk test distance in patients with severe heterogeneous emphysema who have received optimal medical management.
 
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Orthopaedic and Rehabilitation Devices Panel (December 9)
submitted by healthnews 48 days ago (via fda.gov)
The committee will discuss, make recommendations and vote on a premarket approval application for Synvisc-One, sponsored by Genzyme Corp. This device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
 
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Substantially Equivalent 510(k) Device - HCLL Transfusion, v3.0
submitted by information 48 days ago (via fda.gov)
Mediware Information Systems, Inc.
 
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Federal Register: Global Harmonization Task Force, Study Group 1; Proposed and Final Documents; Availability
submitted by healthnews 48 days ago (via edocket.access.gpo.gov)
The FDA is announcing the availability of proposed and final documents that have been prepared by Study Group 1 of the Global Harmonization Task Force (GHTF).
 
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Japanese mobiles to offer psychotherapy sessions (AFP)
submitted by onlinepharmacy 48 days ago (via us.rd.yahoo.com)
AFP - A Japanese professor on Wednesday launched what he said was the world#39;s first web-based psychotherapy sessions available via mobile phone, as the country grapples with a growing problem of depression.
 
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Doctors transplant windpipe with stem cells (AP)
submitted by onlinepharmacy 48 days ago (via us.rd.yahoo.com)
AP - Doctors have given a woman a new windpipe with tissue grown from her own stem cells, eliminating the need for anti-rejection drugs. This technique has great promise, said Dr. Eric Genden, who did a similar transplant in 2005 at Mount Sinai Hospital in New York. That operation used both donor and recipient tissue. Only a handful of windpipe, or trachea, transplants have ever been done.
 
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Stem cells restore hearing, vision in animals (Reuters)
submitted by onlinepharmacy 48 days ago (via us.rd.yahoo.com)
Reuters - Stem cells from tiny embryos can be used to restore lost hearing and vision in animals, researchers said Tuesday in what they believe is a first step toward helping people.
 
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