News & Events

Weekly Media Tip Sheet

 

FDA News & Notes – Week of Nov. 17, 2014  

 
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 Nov. 17, 2014. 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:
 
Monday, 11/17 – Friday 11/21 – FDA Commissioner Margaret A. Hamburg, M.D., will visit China to attend the 9th International Summit of Heads of Medicines Regulatory Agencies Meeting. While there, she will meet with Chinese officials to discuss additional ways the United States. and China can enhance partnerships to strengthen the safety of food and the quality of medical products produced in China and exported to the United States, including the expansion of the FDA’s staffing in China.. Dr. Hamburg will also deliver a speech at Peking University and tour the China Food and Drug Administration’s mobile testing lab used to test counterfeit drugs.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
 
Monday, 11/17 – Friday 11/21 – FDA Deputy Commissioner, Michael R. Taylor, J.D., will participate in four state-sponsored listening sessions on the FDA Food Safety Modernization Act proposed rules. The four proposed rules--Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, and the Foreign Supplier Verification Programs--are currently open for public comment. The Vermont session is November 17; Georgia is November 19; North Carolina is November 20; and Florida is November 21.
Press Office Contacts: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov and Juli Putnam, 240-402-0537, juli.putnam@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:
 
Tuesday, 11/18 – As part of American Public Health Association’s annual meeting, the FDA will deliver two updates on its strategic priorities and progress on tobacco regulation. The presentations are part of the APHA Alcohol, Tobacco and Other Drugs section and aim to help the public health community understand the FDA’s authority to regulate tobacco, how science is used to make the most effective regulatory decisions and how state and local tobacco control efforts can complement and inform this process. The meeting will be held in New Orleans, Louisiana.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov      
 
Tuesday, 11/18 – The Drug Safety and Risk Management Advisory Committee will meet to discuss the Food and Drug Administration Amendments Act of 2007 which requires the FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before the Drug Safety and Risk Management Advisory Committee. The agency plans to discuss the risk management of eculizumab (SOLIRIS). The FDA will seek public input whether the REMS with ETASU for this drug assures safe use of the drug, is not unduly burdensome on patient access to the drug, and to the extent practicable, minimizes the burden on the health care delivery system. The meeting will take place beginning at 9 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov       
 
Wednesday, 11/19 – The Science Board to the FDA will meet to review the existing nonclinical and clinical data related to the use and potential toxicity of anesthetics and sedation drugs in the pediatric population. The Science Board will be asked to make recommendations on steps the FDA should take to further evaluate and to mitigate the risks associated with the use of these drugs in the pediatric population and mechanisms to best communicate with the public regarding this issue. The meeting will take place beginning at 8:30 a.m. on the FDA’ White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
 
Thursday, 11/20 – The Science Board to the FDA will be provided with progress reports from two subcommittees, the Commissioner’s Fellowship Program Evaluation subcommittee and the Science Moving Forward subcommittee. The board will be asked to support the formation of a new subcommittee to evaluate the Office of Regulatory Affairs’ current investments in the Food Emergency Response Network cooperative agreement program and funding for state laboratories to achieve International Organization for Standardization accreditation. The board will also be asked to support the formation of a new subcommittee to evaluate the Centers of Excellence in Regulatory Science and Innovation program. A recipient of one of the fiscal year 2013 Scientific Achievement Awards (selected by the board) will provide an overview of the activities for which the award was given. The meeting will take place beginning at 8:30 a.m. on the FDA’ White Oak Campus, Silver Spring, Maryland.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
 
Friday, 11/21 – The FDA will hold a public workshop titled Brain-Computer Interface (BCI) Devices for Patients with Paralysis and Amputation. The purpose of this workshop is to obtain feedback on scientific, clinical, and regulatory considerations associated with BCI devices. Ideas and suggestions generated during this workshop may facilitate development of draft guidance to provide our initial thoughts regarding the content of premarket submissions for emerging BCI technologies and help to speed development and approval of future submissions. The workshop will take place beginning at 8:30 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.  
Press Office Contacts: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov and Leslie Quander Wooldridge, 240-402-4504, leslie.wooldridge@fda.hhs.gov
 
In Case You Missed It:
 
Thursday, 11/13 – FDA Voice Blog: FDA Approves a Vaccine to Address a Critical Public Health Need – Trumenba-- for Prevention of Serogroup B Meningococcal Disease. Over the last year and a half, there have been numerous reports about outbreaks of bacterial meningitis on several college campuses. Invasive meningococcal disease is a life-threatening illness caused by the bacterium Neisseria meningitidis that infects the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). N. meningitidis is a leading cause of bacterial meningitis, which can have devastating consequences. Between 10 and 15 percent of people who develop meningococcal disease die from the infection, and another 10 to 20 percent suffer permanent complications, such as brain damage or limb loss. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov          
 
Wednesday, 11/12 – Consumer Update: FDA Guards Against Food Spoilage, Contamination. At an FDA laboratory in Jefferson, Arkansas, sensory analysts’ noses—not their microscopes—are their essential tools. These specialists in this FDA regional lab use their senses of smell for detecting odors of decomposition to make sure domestic and imported seafood and seafood products are fit for consumption.
Press Office Contact: Lauren Sucher, 240-402-4793, lauren.sucher@fda.hhs.gov  
                                                      
Monday, 11/10 – FDA Voice Blog: FDA and Asia-Pacific Colleagues Focus on Food Safety. In the alphabet soup of international affairs— UN, NATO, WTO— APEC is perhaps one of the lesser-known entities. In FDA’s world, APEC (Asia-Pacific Economic Cooperation), which focuses on facilitating economic growth, cooperation, trade and investment in the Asia-Pacific region, is a significant focus of collaboration in the area of food safety. Read the entire blog at FDA Voice.
Press Office Contact:  Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov      
 
FDA Office of Media Affairs Contact Information:
 
FDA News & Notes Inquiries: Fallon Smith, 301-796-8632, fallon.smith@fda.hhs.gov
General Inquiries: Call or e-mail FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
 
More Resources:
Read our Blog: FDA Voice
FDA Photos (Flickr)
 
 
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