FDA News & Notes - Week of April 25, 2011

SILVER SPRING, Md., April 25, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights for this week from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of April 25, 2011.

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FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.

Meetings, Workshops and Congressional Testimony:

Wednesday, 4/27 – General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee considers premarket approval application supplement for RESTYLANE, currently approved for mid- to deep-dermal implantation for correction of moderate to severe facial wrinkles. 8 a.m., Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, Md.

Press Office Contact: Sandy Walsh, 301-796-4669, [email protected]

Wednesday, 4/27 – Antiviral Drugs Advisory Committee Meeting discusses a new drug for boceprevir, a hepatitis C virus protease inhibitor, made by Merck & Co. Inc. Proposed for treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults whose liver is damaged but still has the ability to function and who have not been previously untreated or who have failed previous therapy. 8 a.m., 10903 New Hampshire Ave., Room 1503, White Oak Conference Center, Bldg. 31, Silver Spring, Md. The meeting will be webcast.

Press Office Contact: Erica Jefferson, 301-796-4988, [email protected]

Thursday, 4/28 – Antiviral Drugs Advisory Committee Meeting will discuss a new drug application for telaprevir, a hepatitis C virus protease inhibitor, manufactured by Vertex Pharmaceuticals Inc. Proposed for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults whose liver is damaged but still has the ability to function and who have not been previously treated or who have failed previous therapy. 8 a.m., 10903 New Hampshire Ave., Room 1503, White Oak Conference Center, Bldg. 31, Silver Spring, Md. The meeting will be webcast.

Press Office Contact: Erica Jefferson, 301-796-4988, [email protected]

Thursday, 4/28 –The Blood Products Advisory Committee meets to discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing during the morning session. In the afternoon, the committee will discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing. 8:30 a.m., Hilton Washington D.C./North, 620 Perry Pkwy., Gaithersburg, Md.

Press Office Contact: Shelly Burgess, 301-796-4651, [email protected]

Friday, 4/29 – The Blood Products Advisory Committee meets to discuss blood donor written statement of understanding during the morning session. In the afternoon, the committee will hear an update from the Department of Health and Human Services' Office of the Assistant Secretary for Health and an update on public workshops the FDA is considering sponsoring on thrombotic adverse events associated with Immune Globulin Intravenous, toxicities of Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors. 8 a.m., Hilton Washington D.C./North, 620 Perry Pkwy., Gaithersburg, Md.

Press Office Contact: Shelly Burgess, 301-796-4651, [email protected]

Recent Web Postings:

Medical Device Data Systems Rule

Press Office Contact: Karen Riley, 301-796-4674, [email protected]

FDA Office of Public Affairs Contact Information:

Call or email FDA Office of Public Affairs, 301-796-4540, [email protected]

List of FDA press officers and beats

More Resources:

FDA News and Events

FDA Photos (Flickr)

Consumer Health Information

SOURCE U.S. Food and Drug Administration