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Weekly Media Tip Sheet


FDA News & Notes – Week of Sept. 29, 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 Sept. 29, 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, 9/29 – Tuesday, 9/30 – Representatives from all four of FDA’s medical product centers (CBER, CDER, CDRH, and CVM), the U.S. Department of Health and Human Services Office of the Inspector General, the U.S. Department of Justice Consumer Protection Branch, and the Federal Trade Commission will provide information on policy and enforcement activities, recommendations for approaching “gray areas” of advertising and promotion during the annual FDLI Advertising & Promotion Conference. It will be held at the Capitol Hilton in Washington, DC.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
Meetings, Workshops and Congressional Testimony:
Monday, 9/29 – Tuesday, 9/30 – The Food Advisory Committee will meet to discuss risk ranking and risk prioritization approaches for specific regulatory purposes. The Committee will provide input to FDA in the development of the characteristics for data collections and risk ranking/risk prioritization models. The meeting will take place beginning at 8:30 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact:  Lauren Sucher, 240-402-4793, lauren.sucher@fda.hhs.gov   
Wednesday, 10/1 – The Gastroenterology and Urology Devices Panel will meet to discuss, make recommendations, and vote on information regarding the premarket approval application for the Sonablate 450 device sponsored by SonaCare Medical, LLC. The Sonablate 450 is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy. The meeting will take place beginning at 8 a.m. at the Gaithersburg Hilton Hotel, Gaithersburg, Maryland.
Press Office Contact: Morgan Liscinsky, 301-795-0397, morgan.liscinsky@fda.hhs.gov  
On the Web:
Monday, 9/22 – Update to the 515i Project Status webpage: a proposed order to reclassify iontophoresis devices intended for any other puposes as class II (special controls) devices. 
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
Tuesday, 9/23 – Final guidance for Industry and Food and Drug Administration Staff: Custom Device Exemption
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov
In Case You Missed It:
Friday, 9/26 – Display of Federal Register Notices: FDA Reopens Comment Period for Two Draft Social Media Guidances. Beginning September 29, 2014, the public will have an additional 30 days to provide comments on the draft guidances—“Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
Thursday, 9/26 – News Release: U.S. Marshals seize botanical substance kratom from southern California facility. U.S. Marshals at the request of the FDA seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
Press Office Contact: Jennifer Corbett Dooren, 301-795-2983, jennifer.dooren@fda.hhs.gov  
Thursday, 9/25 – News Release: NIH and FDA win top award for intellectual property licensing of meningitis vaccine. The NIH and the FDA will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the Licensing Executives Society at the society’s 50th annual meeting, Oct. 5-8 in San Francisco.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
Thursday, 9/25 – FDA Voice Blog: Reflecting on New Food Protections in the Wake of PCA Convictions. On Sept. 19, 2014, a federal jury in Georgia returned guilty verdicts against two former officials of and one broker for the Peanut Corporation of America (PCA) in connection with practices that led to a 46-state outbreak of Salmonella poisoning in 2009. While there were more than 700 reported cases, including nine deaths, epidemiological projections by the Centers for Disease Control and Prevention put the total number of illnesses at more than 22,000. Read the entire blog at FDA Voice.
Press Office Contact: Juli Putnam, 240-402-0537, juli.putnam@fda.hhs.gov
Wednesday, 9/24 – News Release: FDA clears glucose monitoring system for use in hospital critical care units. The FDA cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov    
Wednesday, 9/24 – FDA Voice Blog: Celebrating 30 years of easier access to cost-saving generic drugs. Thirty years ago today, President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984, better known today as the Hatch-Waxman Amendments. This law, championed by Senator Orrin Hatch and Representative Henry A. Waxman, made it easier for generic drugs to enter the market, and has greatly expanded access to important—often life-saving—drugs. Over the 10-year period 2003 through 2012, generic drug use is estimated to have generated more than $1.2 trillion in savings to the health care system and to have benefitted the health and well-being of innumerable lives. Read the entire blog at FDA Voice.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov      
Wednesday, 9/24 – FDA Voice Blog: The FDA Drug Shortage Assistance Award… Recognizing manufacturers who help prevent or alleviate drug shortages. As part of our continuing commitment to prevent drug shortages and minimize their impact on public health, the FDA has launched the FDA Drug Shortage Assistance Award. Read the entire blog at FDA Voice.
Press Office Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov     
Wednesday, 9/24 – Consumer Update: A Decade of Prostate Cancer Progress. Prostate cancer is the second most common cause of cancer-related deaths among American men. The prostate is a gland in the male reproductive system. It makes most of the semen that carries sperm. The walnut-sized gland is located beneath the bladder and surrounds the upper part of the urethra, the tube that carries urine from the bladder.
Press Office Contact: Stephanie Yao, 301-706-0394, stephanie.yao@fda.hhs.gov   
Tuesday, 9/23 – News Release: FDA food safety challenge to spur new technologies for fighting foodborne illness. The FDA is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.
Press Office Contact: Juli Putnam, 240-402-0537, juli.putnam@fda.hhs.gov
Tuesday, 9/23 – FDA Voice Blog: FDA’s First Food Safety Challenge Targets Salmonella Detection. An estimated one in six Americans is sickened by foodborne illness annually, resulting in about 3,000 deaths each year. To keep our food safe, the FDA wants to develop faster and more sensitive technologies to detect contaminants such as harmful bacteria. That’s why the agency is launching its first Food Safety Challenge, an effort to strengthen our food supply by fostering innovation in technologies that will more quickly detect pathogens in produce. Read the entire blog at FDA Voice.
Press Office Contact: Juli Putnam, 240-402-0537, juli.putnam@fda.hhs.gov
Tuesday, 9/23 – FDA Voice Blog: Three encouraging steps towards new antibiotics. You may have been hearing about a variety of Federal Government actions to address the growing need for new antibiotics. For instance, in an FDA Voice blog last week Commissioner Hamburg discussed the President’s national strategy for Combating Antibiotic Resistant Bacteria (CARB) and our collaboration with a wide variety of organizations to address this issue. You may have also noticed another recent blog talking about the FDA’s work on the Generating Antibiotics Incentives Now Act (GAIN Act), the Antibacterial Drug Development Task Force, a public meeting, a Federal Register Notice, and multiple guidance documents, all aimed at building up the nation’s arsenal of effective antimicrobial drugs. Read the entire blog at FDA Voice.
Press Office Contact: Stephanie Yao, 301-706-0394, stephanie.yao@fda.hhs.gov 
Monday, 9/22 – News Release: FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample. The FDA allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@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
List of FDA Press Officers and beats 
More Resources:
Read our Blog: FDA Voice
FDA Photos (Flickr)
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