Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

News & Events

  • Print
  • Share
  • E-mail
-

Section Contents Menu

Newsroom

-

Weekly Media Tip Sheet

FDA News & Notes – Week of May 20, 2013

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 May 17, 2013. Times listed are local time.

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

 
Events and Speeches for the Commissioner and FDA Leadership:
 
Tuesday, 5/21 – Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research will deliver a keynote address at the Ninth Annual State of Personalized Medicine Luncheon hosted by the Personalized Medicine Coalition. The luncheon will take place at the National Press Club Ballroom in Washington, D.C.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:
 
Tuesday, 5/21 and Wednesday, 5/22 – On May 21, the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will discuss and make recommendations regarding the classification of one of the remaining preamendment class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. On May 22, the committee will discuss and make recommendations regarding the 515(i) order issued by the FDA on April 9, 2009, for one of the remaining preamendment class III devices, pedicle screw spinal systems, intended to treat degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1, or degenerative spondylolisthesis with objective evidence of neurologic impairment. The meeting will take place on both days beginning at 8 a.m. at the Holiday Inn in Gaithersburg (Two Montgomery Village Ave., Gaithersburg, Md.)
Press Office Contact: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov
 
Wednesday, May 22 – The Peripheral and Central Nervous System Drugs Advisory Committee will meet to discuss the new drug application for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed use is for insomnia characterized by difficulties with sleep onset and/or maintenance. The meeting will be held beginning at 8 a.m. in the Great Room, White Oak campus (10903 New Hampshire Ave., Building 31, Silver Spring, Md.). The meeting will be webcast.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
 
Wednesday, May 22 – A Congressional hearing on “Food and Drug Safety, Public Health and the Environment in China,” Congressional-Executive Commission on China.  The hearing will include testimony from Steven M. Solomon, D.V.M., M.P.H., associate director for global operations and policy in the FDA’s Office of Global Regulatory Operations and Policy. It will take place at 10 a.m. in Dirksen Senate Office Building, Room 562, Washington, D.C.
Press Office Contact: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov
 
In Case You Missed It:
 
Friday, 5/17 – FDA Voice Blog: Science is the Foundation of Food Safety at FDA. Science is the foundation of everything we do at the FDA to keep your food safe.
The Food Safety Modernization Act that President Obama signed into law in 2011 emphasizes prevention of foodborne illnesses. Margaret Hamburg, FDA’s commissioner, has made it our priority to base the agency’s regulatory decisions on sound, cutting-edge science.
Press Office Contact: Press Office Contact: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
 
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
 
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
 
Wednesday, 5/15 – FDA Voice Blog: Track Our Success as We Implement New Law. As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the Internet to track our progress.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
 
Wednesday, 5/15 – Consumer Update: Stay Safe in the Summer Sun. As summer approaches, the FDA has taken steps on multiple fronts to protect consumers from the skin damage that can be caused by too much exposure to the sun. This is the first summer in which the FDA’s new rules governing sunscreen labeling are in effect. These rules include allowing only products proven to protect against both UVB and UVA ultraviolet rays to bear the label “broad spectrum.” And the FDA is supporting “Don’t Fry Day” on May 24, 2013, a skin-safety awareness campaign that takes place every year on the Friday before Memorial Day.
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov
 
Tuesday, 5/14 – Consumer Update: FDA’s Role in Regulating Safety of GE Foods. Genetically engineered (GE) foods, also known as biotech foods and referred to by some as food from genetically modified organisms (GMOs), have been in our food supply for about 20 years. Genetic engineering refers to certain methods that scientists use to introduce new traits or characteristics to an organism. For example, plants may be genetically engineered to produce characteristics that enhance the growth or nutritional value of food crops. Using a science-based approach, the FDA regulates foods and ingredients made from genetically engineered plants to help ensure that they are safe to eat.
Press Office Contact: Theresa Eisenman, 301-796-2805, theresa.eisenman@fda.hhs.gov
 
Monday, 5/13 - FDA Voice Blog: Food Defense – What’s Your Plan? While food safety – preventing unintentional contamination from sources likely to be found in the food chain – is a priority for the FDA, so is food defense – protecting our food from intentional contamination by saboteurs, terrorists or other criminals. Recently, we released a new tool that will help the owners and operators of food facilities develop customized food defense plans to minimize the risk of intentional contamination. It’s a software program called the Food Defense Plan Builder and it’s designed to be easy to use.
Press Office Contact: Theresa Eisenman, 301-796-2805, theresa.eisenman@fda.hhs.gov

 

FDA Office of Media Affairs Contact Information:

FDA News & Notes inquiries: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov

General Inquiries: Call or email FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
List of FDA Press Officers and beats

More Resources: 
FDA News and Events
Consumer Health Information 
Read our Blog: FDA Voice

Visit the FDA on Facebook disclaimer icon , Flickr disclaimer icon , YouTube disclaimer icon  and Twitter disclaimer icon 
 

 

-
-
-