FDA News & Notes - Week of January 2, 2012
SILVER SPRING, Md., Jan. 3, 2012 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights 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 January 2, 2012.
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FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
Meetings, Workshops and Congressional Testimony:
Friday, 1/6 - The FDA Science Board discusses the Centers for Excellence in Regulatory Science and Innovation, an update regarding the Scientific Computing/JANUS program, and other matters. 9 a.m., 10903 New Hampshire Avenue, Building 31, Room 1503, Silver Spring, Md. The meeting will be webcast. Please note that visitors to the FDA White Oak Campus must enter through Building 1.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Wednesday, 1/11 - The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee discusses the premarket approval application for the LINX Reflux Management System sponsored by Torax Medical, Inc. 8 a.m., Hilton Washington DC North/Gaithersburg, 620 Perry Parkway, Gaithersburg, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
On the Web:
Draft Guidance for Industry and Food and Drug Administration Staff - CDRH Appeals Processes
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
FDA Office of Public Affairs Contact Information:
Call or email FDA Office of Public Affairs, 301-796-4540, fdaopa@fda.hhs.gov
List of FDA press officers and beats
More Resources:
FDA News and Events
FDA Photos (Flickr)
SOURCE U.S. Food and Drug Administration